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  • A Phase 1b Study of the OxPhos Inhibitor ME-344 Combined with Bevacizumab in Previously Treated Metastatic Colorectal Cancer. - NCT05824559

    Primary Objective: To estimate progression-free survival (PFS) at 16 weeks of treatment in subjects with mCRC administered ME-344 in combination with bevacizumab. Secondary Objective: 1. To evaluate the preliminary efficacy of ME-344 administered in combination with bevacizumab in subjects with mCRC. 2. To determine the safety and tolerability of ME-344 administered in combination with bevacizumab. 3. To evaluate the pharmacokinetics (PK) of ME-344 administered in combination with bevacizumab. Exploratory Objective: To evaluate correlatives of mitochondrial metabolism.

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    • Protocol Number:
      072304

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Colon,Rectum

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB ME-344

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age ≥18 years
    • Histological or cytological documentation of adenocarcinoma of the colon or rectum that is metastatic (all other histological types are excluded)
    • Subjects who progressed or demonstrated intolerability to prior standard approved therapies which include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapies, cetuximab/panitumumab (if clinically indicated e.g., RAS wild-type tumors) PD-1 or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors in the metastatic setting.
    • Previous treatment with any investigational drug or anticancer treatment must be completed >28 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
    • Adequate bone marrow, liver, and renal function

    Exclusion Criteria:

    • Untreated brain metastases, spinal cord compression, or primary brain tumor
    • Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
    • Evidence of uncontrolled or unstable cardiovascular disease, myocardial infarction (within 6 months), unstable angina pectoris, congestive heart failure, serious arrhythmias requiring drug therapy
    • History of CNS disease
    • Bevacizumab or aflibercept therapy ≤ 3 weeks prior to starting study treatment
    • Peripheral neuropathy Grade ≥ 2
    • Uncontrolled hypertension or diabetes mellitus, active peptic ulcers, unhealed wounds, clinically significant disease or systemic infections
    • Known seropositive for, or active infection with hepatitis B or C virus
    • Symptomatic or uncontrolled infection with human T-cell leukemia virus
    • Venous thromboembolism (unless appropriately treated and stable on anticoagulant for at least 2 weeks).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Basket Trial of Ulixertinib (BVD-523) in Combination with Hydroxychloroquine in Patients with Advanced Gastrointestinal Malignancies Harboring MAPK Pathway Mutations. - NCT05221320

    Primary Objective: - To assess the safety and tolerability of ulixertinib and hydroxychloroquine in patients with advanced, RAS, non-V600 BRAF, MEK1/2, or ERK1/2 mutated gastrointestinal (GI) malignancies. - To assess the efficacy of ulixertinib and hydroxychloroquine in patients with advanced, RAS, non-V600 BRAF, ERK1/2, or MEK1/2 mutated gastrointestinal malignancies. Secondary Objective: - To assess the duration of efficacy of ulixertinib and hydroxychloroquine in patients with advanced RAS, non- V600 BRAF, MEK1/2, or ERK1/2 mutated gastrointestinal malignancies. Exploratory Objective: - To evaluate the bioactivity of ulixertinib and hydroxychloroquine against ERK1/2, autophagy pathways, and pharmacodynamic biomarkers.

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    • Protocol Number:
      052216

    • Principal Investigator:
      Sanjay Goel

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Anus,Small Intestine,Colon,Esophagus,Stomach,Rectum,Other Digestive Organ,Pancreas

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Ulixertinib (BVD-523) Hydroxychloroquine

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sanjay Goel

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patient aged ≥ 18 years. 2. Histologically confirmed esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, extrahepatic cholangiocarcinoma, or colorectal adenocarcinoma harboring a MAPK-mutated GI malignancy: KRAS, NRAS, HRAS, BRAF non-V600, MEK 1/2 (MAP2K1/2), or ERK 1/2 (MAPK3/1). 3. Progression on or during standard lines of therapy:
    • Patients with intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, or extrahepatic cholangiocarcinoma must have progressed during or after receiving a first-line regimen of gemcitabine/cisplatin unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with pancreatic adenocarcinoma must have progressed during or after first-line therapy of FOLFIRINOX/ mFOLFIRINOX, gemcitabineab-paclitaxel unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with colorectal adenocarcinoma must have progressed during or after their first two lines of therapy, including FOLFOX ± Avastin and FOLFIRI ± Avastin, unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, or gastric adenocarcinoma must have progressed during or after their first two lines of therapy.
    • Acceptable first-line regimens: FOLFOX, 5-FU/Cisplatin, FOLFIRI, Paclitaxel/Cisplatin or Carboplatin, Docetaxel/Cisplatin, DCF (or modifications thereof), or ECF (or modifications thereof) unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Acceptable second-line regimens: Ramucirumab/Paclitaxel, Docetaxel, Paclitaxel, Irinotecan, Trifluridine/Tipiracil, or FOLFIRI, unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
    • Patients with deficient MisMatch Repair/High levels of MicroSatellite Instability (dMMR/MSI-H) tumors must have progressed during or after pembrolizumab. 4. Measurable disease by RECIST 1.1 criteria by computed tomography (CT) or magnetic resonance imaging (MRI). 5. Willing to provide a biopsy at the time points indicated on the Schedule of Activities. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 7. Adequate organ function as defined as: Hematologic:
    • Absolute neutrophil count (ANC) ≥ 1500/mm3
    • Platelet count ≥ 100,000/mm3
    • Hemoglobin ≥ 9 g/dL Hepatic:
    • Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
    • Asparate animotransferace /Alanine aminotransferase (AST(SGOT)/ALT(SGPT)) ≤ 3 × institutional ULN
    • Patients with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN. Renal:
    • Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula:
    • Males: (140-age) × weight [kg] / serum creatinine [mgdL] × 72
    • Females: ((140-age) × weight [kg] / serum creatinine [mgdL] × 72)×0.85 8. For female patients: Negative serum pregnancy test within 72 hours prior to first dose of study drugs for women of childbearing potential. The following definitions apply:
    • Women of childbearing potential, defined as a sexually mature woman:
    • Has not been naturally post-menopausal for at least 12 consecutive months (i.e., who has had menses anytime in the preceding 12 consecutive months).
    • Has not undergone menopause, surgical sterilization (bilateral oophorectomy or hysterectomy).
    • Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
    • Women not of childbearing potential:
    • Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, if any.
    • Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 9. Male and female patients of childbearing potential agree to use highly effective contraception throughout the study and at least 90 days after the last study treatment administration. 10. Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator. 11. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

    Exclusion Criteria:

      1. Received systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter. 2. Received radiotherapy ≤ 14 days prior to the first dose of study treatment. Note: Localized radiation therapy for the treatment of symptomatic bone metastasis is allowed during that timeframe. 3. Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not fully recovered from major surgery. 4. The diagnosis of another malignancy within ≤ 3 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). 5. Known uncontrolled brain metastases or cranial epidural disease. Note: Patients with stable brain metastases either treated or being treated with a stable dose of steroids (<20 mg of prednisone daily or equivalent) or anticonvulsants, with no dose change within 4 weeks before the first study drug dose, and no anticipated dose change, are eligible. In the event of steroid taper post-radiation therapy, taper must be complete within 2 weeks before Baseline. 6. History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity). 7. Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions: Cardiovascular disorders:
    • Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
    • Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
    • Duration of QT interval (QTc prolongation) defined as a QTcF > 500 ms.
    • Known congenital long QT.
    • Left ventricular ejection fraction < 50%. History of seizures Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome). Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [patients may not receive the drug through a feeding tube], social/ psychological issues, etc.) 8. Prior stomach or duodenal resection that in the opinion of the Principal Investigator and Medical Monitor would affect the breakdown and absorption of the study medications. A patient with a feeding tube should also be excluded, as ulixertinib capsules cannot be broken apart. 9. Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Patients on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial. 10. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C. Note: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 11. Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study. 12. Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3). 13. Patients taking prohibited medications as described in protocol. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur before the start of treatment.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of CTX-009 in Adult Patients with Metastatic Colorectal Cancer who have received Two or Three Prior Systemic Chemotherapy Regimens. - NCT05513742

    Primary Objective: - To assess the efficacy of CTX-009 in patients with colorectal cancer (CRC) who have received two or three systemic therapies for advanced disease, as measured by Overall Response Rate (ORR). Secondary Objective: - To assess the efficacy of CTX-009 in patients with CRC as measured by Disease Control Rate (DCR). - To assess the efficacy of CTX-009 in patients with CRC as measured by Duration of Response (DOR). - To assess the efficacy of CTX-009 in patients with CRC as measured by Progression Free Survival (PFS). - To assess the efficacy of CTX-009 in patients with CRC as measured by Overall Survival (OS). - To evaluate the safety profile of CTX-009, including immunogenicity of CTX-009 in treated patients.

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    • Protocol Number:
      072301

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      CTX-009

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. 18 years of age or older 2. Histologically or cytologically confirmed metastatic or recurrent colorectal cancers 3. The primary tumor must have been resected > 3 months prior to planned C1D1. 4. Patients who experienced progressive disease or relapse after receiving two or three prior lines of systemic therapy in the locally advanced or metastatic setting. Prior lines of systemic treatment must have included at least one fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab containing chemotherapy regimen (in any combination and may have been administered in the neoadjuvant setting). 1. Patients whose tumor is not right sided and RAS wild type must also have received an anti-epidermal growth factor receptor (EGFR) therapy. 2. Patients with tumors harboring mutations or other alterations for which there are available targeted therapies (e.g. BRAF V600E, HER2-positive, MSI-H/dMMR, etc.) must have also received the relevant approved targeted therapies. 3. If patient received peri-operative treatment (neoadjuvant and/or adjuvant), please consult the Sponsor Medical Monitor for review of prior treatment lines. 5. At least one lesion measurable as defined by RECIST v1.1 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 7. Predicted life expectancy of at least 12 weeks 8. Adequate hepatic and renal function within 14 days of C1D1 as described below: 1. Total bilirubin ≤ 1.5 X upper limit of normal (ULN) 2. Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) ≤ 3.0 X ULN (≤ 5x ULN in case of hepatic metastasis) 3. Estimated creatinine clearance ≥ 30 mL/min based on Cockcroft-Gault estimated creatinine clearance 4. Urine protein ≤ 1+ by spot urinalysis (or, if > 1+ then 24 hr urine protein <1.0 g/24 hr) 9. Female patients who are women of childbearing potential (WCBP) must have a negative pregnancy test (serum-human chorionic gonadotropin [hCG] or urine-hCG) at Screening within 14 days of C1D1 10. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commit to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives, or abstinence) for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment 11. Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) before any protocol-directed screening procedures are performed

    Exclusion Criteria:

      1. From the time point of signed informed consent, 1. Less than 4 weeks have elapsed since patients had a surgery or major procedure 2. Less than 2 weeks have elapsed from the last treatment date since patients had any radiation therapy 2. Prior to planned C1D1, 1. Less than 4 weeks have elapsed since patients had chemotherapy or targeted therapy for colorectal cancer 2. Less than 4 weeks have elapsed since patients had anticancer immunotherapy or investigational drug treatment 3. A history of the following cardiovascular diseases in past 5 years may be exclusionary, as determined by the Sponsor Medical Monitor: 1. Congestive heart failure that corresponds to Class II or a higher class under New York Heart Association (NYHA) classification or less than 50% of left ventricular ejection fraction (LVEF) 2. Uncontrolled hypertension (systolic blood pressure [SBP]/diastolic blood pressure [DBP] > 140/90 mmHg) (e.g., patient with SBP/DBP > 140/90 mmHg despite the best care including anti-hypertensive medications) 3. Patients with a history of hypertensive crisis or pre-existing hypertensive encephalopathy 4. Pulmonary hypertension 5. Myocardial infarction 6. Uncontrolled arrhythmia 7. Unstable angina 8. Patients with any significant vascular diseases (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to the initial treatment of the investigational product 4. Symptomatic or uncontrolled central nervous system (CNS) metastasis (However, patients with asymptomatic CNS metastasis can participate provided that systemic corticosteroid treatment was discontinued at least 4 weeks prior to screening and that the patient is radiologically and neurologically stable or improving) 5. A history of the following hemorrhage-related or gastroenterological disease: 1. Active hemorrhage, hemorrhagic diathesis, coagulopathy or tumor invasion into great arteries 2. History of clinically significant and active (within 6 months) gastroenterological disease, such as peptic ulcer, gastrointestinal (GI) bleeding, GI or non-GI fistula, perforation, abdominal abscess, clinical symptoms and signs of GI obstruction, need for parenteral hydration or nutrition, or inflammatory bowel disease. 6. Patients who received antiplatelet drugs (aspirin, clopidogrel, etc.) or anticoagulant drugs (warfarin, heparin, direct thrombin inhibitors, etc.) within 2 weeks prior to C1D1, or are expected to need those drugs during the clinical study. 7. Patients requiring continuous treatment with systemic non-steroidal anti-inflammatory drugs (NSAIDs) or systemic corticosteroids (the following cases are permitted): 1. NSAIDs: Up to 3 consecutive days' use is permitted 2. Corticosteroids: Topical use of corticosteroid, such as topical intra-articular injection, intranasal administration, eye drops, inhaler, etc., or temporary systemic corticosteroid use for treatment and prevention of patient's contrast media allergy, or adverse event, is permitted 8. Severe infection requiring systemic antibiotics, antivirus drugs, etc., or other uncontrolled acute active infectious diseases 9. Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Inactive hepatitis B carriers who tested HBsAg positive may enroll provided that the patient's liver function values are normal. Also, patients with chronic HBV infection which has been controlled by the site's treatment guideline may enroll. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll 10. Patients with other severe diseases or uncontrolled illnesses that warrant the exclusion from the study (permitted only if medically controlled) including but not limited to: 1. Pre-existing hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to screening 2. Major, unhealed injury, active ulcer or untreated fracture 3. History of cerebrovascular incident (ischemic or hemorrhagic stroke), transient ischemic attack or subarachnoid hemorrhage within 6 months prior to screening 4. Moderate to severe ascites and/or pleural effusion 11. Clinically significant abnormal electrocardiography (ECG) findings or history determined as clinically significant by the Investigator 12. QT interval (Fridericia's formula) (QTcF) interval > 450 msec at the time of screening

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Jersey City Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 2/3, Randomized, Open-Label Study of Maintenance GRT-C901/GRT-R902, A Neoantigen Vaccine, in Combination with Immune Checkpoint Blockade for Patients with Metastatic Colorectal Cancer. - NCT05141721

    Primary Objectives: To characterize the antitumor activity of maintenance therapy with GRT-C901/GRT-R902 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab as assessed by molecular response based on change in ctDNA in patients with metastatic colorectal cancer (CRC) whose disease has not progressed during induction chemotherapy with fluoropyrimidine/oxaliplatin/bevacizumab. Secondary Objectives: - To evaluate PFS based on RECIST and iRECIST criteria, as assessed by the Investigator, of patients treated with maintenance therapy GRT-C901/GRTR902 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab in patients with metastatic CRC whose disease has not progressed during induction chemotherapy with fluoropyrimidine/oxaliplatin/bevacizumab - To assess the safety and tolerability of GRT-C901/GRT-R902 in combination with checkpoint inhibitors in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab. - To assess OS in patients treated with GRT-C901/GRT-R902 in combinationwith checkpoint inhibitors and fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab. - To evaluate measures of clinical activity of GRT-C901 and GRT-R902 in combination with checkpoint blockade and fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab via RECIST v1.1 and iRECIST-based assessment of: - Objective response rate (ORR) - Duration of response (DOR) - Clinical benefit rate (CBR) - Deepening of response for patients who achieved stable disease (SD) or better response to routine therapy. - To determine the feasibility of manufacturing a patient-specific vaccine.

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    • Protocol Number:
      072110

    • Principal Investigator:
      Lyudmyla Berim

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Rectum,Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic Vaccine

    • Drugs Involved:
      IPILIMUMAB (MDX-010) Atezolizumab (MPDL3280A) GRT-C901 BEVACIZUMAB GRT-R902

      • Contacts:

      • Rutgers University Prinicipal Investigator: Lyudmyla Berim

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients with histologically confirmed metastatic colorectal cancer (CRC) who are planned for, or have received <30 days of first-line treatment in the metastatic setting with FOLFOX/bev, CAPEOX/bev, FOLFOXIRI/bev, or CAPOXIRI/bev per SOC
    • Measurable and unresectable metastatic disease according to RECIST v1.1
    • Availability of formalin-fixed paraffin-embedded (FFPE) tumor specimens.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Patient has adequate organ function per defined criteria
    • If women of childbearing potential (WCBP), must be willing to undergo pregnancy testing and agrees to the use at least 1 highly effective contraceptive method during the study treatment period and for 150 days after last investigational study treatment.

    Exclusion Criteria:

    • Patients with deficient mismatch repair (dMMR) or microsatellite instability (MSI-H) phenotype
    • Patient has a known tumor mutation burden <1 non-synonymous mutations/megabase
    • Known DNA Polymerase Epsilon mutations
    • Patients with known BRAFV600E mutations
    • Bleeding disorder or history of significant bruising or bleeding following IM injections or blood draws
    • Immunosuppression anticipated at time of study treatment
    • History of allogeneic tissue/solid organ transplant
    • Active or history of autoimmune disease or immune deficiency
    • Patient with symptomatic or actively progressing central nervous system (CNS) metastases, carcinomatous meningitis, or has been treated with whole brain radiation
    • History of other cancer within 2 years with the exception of neoplasm that has undergone potentially curative therapy
    • Any severe concurrent non-cancer disease that, in the judgment of the Investigator, would make the patient inappropriate for the current study
    • Active tuberculosis or recent (<2 weeks) clinically significant infection, evidence of active hepatitis B or hepatitis C, or known history of positive test for HIV
    • History of pneumonitis requiring systemic steroids for treatment (with the exception of prior resolved in-field radiation pneumonitis)
    • Myocardial infarction within previous 3 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure (Class III or IV).
    • Pregnant, planning to become pregnant, or nursing.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pretreated Metastatic Colorectal Cancer. - NCT04109924

    Primary Objective: Determine the median progression free survival (PFS) benefit of FOLFIRI naive patients treated with TAS-102 + irinotecan + bevacizumab as compared to historic control groups treated with FOLFIRI + bevacizumab. Secondary Objective: Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile.

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    • Protocol Number:
      071914

    • Principal Investigator:
      Patrick Boland

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB IRINOTECAN TAS-102

      • Contacts:

      • Rutgers University Prinicipal Investigator: Patrick Boland

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Advanced colorectal cancer (metastatic or unresectable): Histologically or cytological proven adenocarcinoma of the colon or rectum which is metastatic or otherwise incurable
    • Prior treatment with a fluoropyrimidine (5-fluorouracil [5-FU] or capecitabine) and oxaliplatin in the metastatic/unresectable setting OR, recurrence within 12 months of adjuvant therapy with a regimen that included oxaliplatin
    • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Hemoglobin >= 9 g/dL
    • Absolute neutrophil count >= 1500/mm^3
    • Platelet count >= 100,000/mm^3
    • Creatinine < 1.5 upper limit of normal (ULN) or if >= 1.5 x ULN creatinine clearance (CRCL) >= 30 mL/min (by Cockcroft-Gault)
    • Bilirubin < 1.5 x ULN
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN or =< 5 x ULN if with hepatic metastases
    • Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present
    • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
    • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

    Exclusion Criteria:

    • Prior treatment with TAS-102 or irinotecan
    • Anti-cancer therapy within 2 weeks of the planned first dose of study medication
    • Unresolved toxicities from prior therapy of > grade 1, excluding alopecia or similar toxicities which are not deemed to be clinically significant or put the participant at greater risk. Grade 2 neuropathy is permitted
    • Major surgery within 4 weeks of anticipated start of therapy
    • Uncontrolled hypertension: systolic blood pressure >= 150, diastolic blood pressure >= 100
    • Unstable angina, symptomatic congestive heart failure or cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers and digoxin are allowed)
    • Arterial or venous thrombotic or embolic events within 3 months of study initiation, unless well controlled on stable anti-coagulation for >= 2 weeks. This excludes uncomplicated catheter associated venous thrombosis
    • History of cerebrovascular or myocardial ischemia within 6 months of initiation
    • National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 grade 3 or greater hemorrhage within the past 4 weeks
    • Proteinuria >= 2+, unless 24 hour urine collection demonstrates =< 1 g of protein OR spot protein: creatinine demonstrates a ratio of =< 1
    • Untreated brain metastases
    • History of abnormal glucuronidation of bilirubin (Gilbert's syndrome)
    • History of second primary malignancy within 3 years prior to enrollment, excluding in-situ cervical carcinoma, non-melanoma skin cancer or malignancy of equivalent risk which is highly unlikely to require systemic treatment in the next 2 years
    • Have known active infection which would heighten the risk of complications
    • Pregnant or nursing female participants
    • Unwilling or unable to follow protocol requirements
    • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line Therapy. - NCT04793958

    Primary Objective: To compare the efficacy of MRTX849 in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation. Secondary Objectives: 1. To evaluate secondary efficacy endpoints in the study population. 2. To evaluate the safety and tolerability in the study population. 3. To evaluate the pharmacokinetics (PK) of MRTX849 administered in combination with cetuximab. 4. To evaluate health-related quality of life (HRQOL) and cancer-related symptoms in the study population.

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    • Protocol Number:
      072102

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CETUXIMAB mFOLFOX6 MRTX849

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
    • Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

    Exclusion Criteria:

    • Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
    • Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
    • Active brain metastasis

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer. - NCT02997228

    Primary Objective: 1.1.1 To determine the efficacy, based on PFS, of mFOLFOX6/bevacizumab plus atezolizumab(combination) and atezolizumab (single agent) as compared to mFOLFOX6/bevacizumab(control). 1.2 Secondary Objectives: 1.2.1 To compare the overall survival. 1.2.2 To compare the objective response rates (ORR) per RECIST 1.1. 1.2.3 To determine the safety profiles of the combination of mFOLFOX6/bevacizumab/atezolizumab and atezolizumab monotherapy in patients with dMMR mCRC. 1.2.4 To compare the surgical conversion rate. 1.2.5 To compare disease control rate (CR + PR + SD) at 12 months. 1.2.6 To determine the duration of response and stable disease. 1.2.7 To determine the progression-free survival (PFS) by retrospective central independent scan review. 1.3 Exploratory Objectives: 1.3.1 To compare the health-related quality of life and patient-reported symptoms. 1.4 Translational Objectives: 1.4.1 To bank tissue and blood samples for other future correlative studies from patients enrolled on the study.

    View All Details

    • Protocol Number:
      071807

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      mFOLFOX6 Atezolizumab (MPDL3280A) BEVACIZUMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
    • Age >= 18 years
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    • Diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer except for one cycle of FOLFOX or capecitabine and oxaliplatin (CAPOX), either with or without bevacizumab prior to enrollment. Upon enrollment, the preceding single cycle of FOLFOX or FOLFOX + bevacizumab, if the patient received one, will not count towards patients' assessments per protocol. Cycle 1 day 1 (C1D1) of atezolizumab or C1D1 of mFOLFOX6/bevacizumab + atezolizumab will correspond to the first day the patient received therapy on trial
    • Tumor determined to be mismatch-repair deficient (dMMR) by Clinical Laboratory Improvement Act (CLIA)-certified immunohistochemical (IHC) assay with a panel of all four IHC markers, including MLH1, MSH2, PMS2, and MSH6; alternatively, MSI-H diagnosed by polymerase chain reaction (PCR)-based assessment of microsatellite alterations (either Bethesda markers or Pentaplex panel) or by next-generation sequencing (NGS) are eligible
    • Documentation by PET/CT scan, CT scan, or MRI that the patient has measurable metastatic disease per RECIST 1.1
    • No immediate need for surgical intervention for the primary tumor or palliative diversion/bypass
    • Absolute neutrophil count (ANC) must be >= 1500/mm^3 (obtained within 28 days prior randomization)
    • Platelet count must be >= 100,000/mm^3 (obtained within 28 days prior randomization)
    • Hemoglobin must be >= 8 g/dL (obtained within 28 days prior randomization)
    • Total bilirubin must be =< 4 x ULN (upper limit of normal) (obtained within 28 days prior randomization); and
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be =< 3 x ULN for the lab with the following exception: for patients with documented liver metastases, AST and ALT must be =< 5 x ULN (obtained within 28 days prior randomization)
    • Calculated creatinine clearance >= 30 mL/min (obtained within 28 days prior randomization)
    • A urine sample tested for proteinuria by either the dipstick method, urinalysis (UA), or a urine protein creatinine (UPC) ratio:
    • The dipstick method must indicate 0-1+ protein; if dipstick reading is >= 2+, a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours or a UPC ratio < 1.0
    • A urine protein creatinine (UPC) ratio must be < 1.0; if the UPC ratio is >= 1.0 a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours
    • Urinalysis must indicate < 30 mg/dl. If urinalysis >= 30 mg/dl, a 24-hour urine must be done and it must demonstrate < 1.0 g of protein per 24 hours or a UPC ratio < 1.0
    • International normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history, regardless of PT/INR results
    • Pregnancy test done within 28 days prior randomization must be negative (for women of childbearing potential only); pregnancy testing should be performed according to institutional standards; administration of atezolizumab or mFOLFOX6/bevacizumab/atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
    • Women of child-bearing potential and men must agree to use adequate contraception methods that result in a failure rate of < 1% per year during the treatment period (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, and 6 months after the last dose of mFOLFOX6; a woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus); examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices; the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception; men must refrain from donating sperm during this same period

    Exclusion Criteria:

    • Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, fluoropyrimidines, folic acid derivatives or oxaliplatin
    • Uncontrolled high blood pressure defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 100 mmHg with or without anti-hypertensive medication; patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria
    • Documented New York Heart Association (NYHA) class III or IV congestive heart failure
    • Serious or non-healing wound, skin ulcer, or bone fracture
    • History of inherited bleeding diathesis, gastrointestinal (GI) perforation, significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis or symptomatic peripheral ischemia, transient ischemic attack [TIA], cerebrovascular accident [CVA] or arterial thrombotic event), abdominal fistula, intra-abdominal abscess, or active GI bleeding (with cause not addressed) within 6 months prior to randomization, or other medical condition in the opinion of the treating oncologist that makes the risk of cardiovascular or bleeding complications with bevacizumab use unacceptably high
    • Other malignancies are excluded unless the patient has completed therapy for the malignancy >= 12 months prior to randomization and is considered disease-free; patients with the following cancers are eligible if diagnosed and treated within the past 12 months: in situ carcinomas or basal cell and squamous cell carcinoma of the skin
    • Known DPD (dihydro pyrimidine dehydrogenase) deficiency
    • Symptomatic peripheral sensory neuropathy >= grade 2 (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0)
    • Prior treatment with oxaliplatin chemotherapy within 6 months prior to randomization
    • History of grade 2 hemoptysis (defined as 2.5 mL of bright red blood per episode) within 1 month prior to screening
    • Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents; patients who have received prior treatment with anti-CTLA-4 may be enrolled provided the following requirements are met:
    • Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose to randomization
    • No history of severe immune-related adverse effects (CTCAE grade 3 and 4) from anti-CTLA-4
    • Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization; however,
    • Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea; or chronic daily treatment with corticosteroids with a dose of =< 10 mg/day methylprednisolone equivalent) may be enrolled
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease; however,
    • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HbsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible if polymerase chain reaction (PCR) for hepatits B virus (HBV) ribonucleic acid (RNA) is negative per local guidelines
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA per local guidelines
    • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; however,
    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
    • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
    • Rash must cover less than 10% of body surface area (BSA)
    • Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
    • No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
    • History of idiopathic pulmonary fibrosis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or active or recently active (within 90 days of randomization) pneumonitis (including drug induced) that required systemic immunosuppressive therapy (i.e. corticosteroids, etc.). History of radiation pneumonitis in the radiation field (fibrosis) is permitted
    • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    • Patients with known active tuberculosis (TB) are excluded
    • Severe infections within 28 days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
    • Signs or symptoms of infection within 14 days prior to randomization
    • Received oral or intravenous (IV) antibiotics within 14 days prior to randomization; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible
    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
    • The administration of a live, attenuated vaccine within 28 days prior to randomization
    • Pregnant women are excluded from this study because atezolizumab is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding should be discontinued if the mother is treated with atezolizumab; these potential risks may also apply to other agents used in this study; (Note: pregnancy testing should be performed within 28 days prior to randomization according to institutional standards for women of childbearing potential)
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
    • Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • Rutgers Cancer Institute of New Jersey
  • A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery. - NCT05296681

    PRIMARY ENDPOINT: Dose Intensity of Irinotecan administered (mg/m2/week) SECONDARY ENDPOINTS: 1. Reduction in % Patients Needing Dose Modification for Diarrhea 2. Toxicity Grade of diarrhea 3. Response Rate 4. Time to Progression-free survival EXPLORATORY ENDPOINTS: 1. 16S rRNA gene sequencing to reveal changes of the gut microbiota including institution of foundation guilds and restoration of healthy microbiome 2. Short chain fatty acids analysis (promotion of acetic and butyric acid production) 3. Markers for gut inflammation such as fecal lipocalin 2 4. Gut barrier function test to see if the restoration of healthier gut microbiota would improve gut barrier function.

    View All Details

    • Protocol Number:
      072201

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy (NOS) Chemotherapy multiple agents systemic

    • Drugs Involved:
      NBT-NM108 IRINOTECAN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Biopsy proven and metastatic colon cancer
    • Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w. Participants who have had prior irinotecan will be eligible if they are off irinotecan for at least three months and stools have returned to baseline consistency.
    • Performance Status (PS) 0-1
    • Lab values as acceptable for trials: Absolute Neutrophil Count( ANC) >1500/uL; Creatinine < 1.5 x Upper Limit of Normal (ULN); Transaminases < 5x ULN; Bilirubin < 1.5 x ULN; Albumin > 3.0 g/dL
    • No known UGTA1A* genotype

    Exclusion Criteria

    • Grade two diarrhea or greater (4-6 movements per day over baseline)
    • Inability to take oral supplements
    • Current antibiotic therapy
    • Baseline grade 3-4 diarrhea Participants with grade two diarrhea should undergo stool evaluation with stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea. They will be eligible if this evaluation shows no infection.
    • History of the following infections and/or disease which could lead to diarrhea:
    • History of prior positive gastrointestinal biopsy, gastrointestinal culture, or stool test for bacteria (Salmonella, Shigella, Campylobacter, Yersinia, Mycobacterium), bacterial toxin (Clostridium difficile), ova and parasites (Giardia, Entamoeba, Isospora, Cyclospora, Cryptosporidium, Microsporidium), or viruses (Cytomegalovirus), associated with an ongoing active infection and diarrhea unless fully treated with at least three months normal stool.
    • History of ulcerative colitis, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • Colon Adjuvant Chemotherapy Based On Evaluation of Residual Disease. - NCT05174169

    Primary Objective ctDNA-ve Cohort (Arms 1 + 2): Phase II: To compare time to ctDNA (+ve) status in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. Time to positive event is defined as time from randomization to the first ctDNA positive result for the immediate arm (Arm 1) and to the 2nd ctDNA positive result for the delayed arm (Arm 2) to allow for the potential effect of delayed adjuvant chemotherapy. Patients recurred without a positive ctDNA result will be considered to have ctDNA positive status at the time of recurrence for both study arms. Phase III: To compare time to DFS event (recurrence, second primary colorectal cancer or death) in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. ctDNA+ve Cohort (Arms 3 + 4): Phase II and III: To compare time to DFS event (recurrence, second primary colorectal cancer or death) in ctDNA (+ve) cohort following resection of colon cancer treated with 5-FU (or capecitabine) and oxaliplatin x 6 months or 5-FU, oxaliplatin and irinotecan x 6 months. Secondary Objectives - To describe the prevalence of detectable ctDNA in patients with stage III colon cancer following surgical resection. The finding will be reported together with the main results of the Phase II portion of the trial. - To estimate time-to-event outcomes (overall survival and time to recurrence) by ctDNA marker status and treatment. - To assess the compliance of adjuvant chemotherapy.

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    • Protocol Number:
      072207

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Radiotherapy Chemotherapy (NOS) Chemotherapy multiple agents systemic

    • Drugs Involved:
      CAPOX mFOLFIRINOX mFOLFOX6

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      The patient must have an ECOG performance status of 0 or 1. Patients must have histologically/pathologically confirmed colon adenocarcinoma (T1-3, N1/N1c) with R0 resection accordingly to AJCC 8th edition criteria. NOTE: Patients with pathologic stages II or IIIC colon adenocarcinoma with R0 resection who have a commercially obtained Signatera™ ctDNA+ve assay result post-operatively meeting all timelines and eligibility requirements otherwise, are eligible for enrollment and inclusion in Cohort B. No radiographic evidence of overt metastatic disease within 28 days prior to study entry (CT with IV contrast or MRI imaging is acceptable and must include chest, abdomen, and pelvis). The distal extent of the tumor must be greater than or equal to 12 cm from the anal verge on colonoscopy or above the peritoneal reflection as documented during surgery or on pathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). The patient must have had an en bloc complete gross resection of tumor (curative resection). Patients who have had a two-stage surgical procedure, to first provide a decompressive colostomy and then in a later procedure to have the definitive surgical resection, are eligible. The resected tumor specimen and a blood specimen from patients with Stage IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera™ assay by Natera. NOTE: Patients with stage IIIA or IIIB colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study, are allowed to be enrolled, and will be retested and placed in either Cohort A or Cohort B depending on the central ctDNA testing result. NOTE: Patients with stage II or IIIC colon cancer who otherwise meet eligibility criteria and have had ctDNA status checked with the Signatera™ assay as routine care outside of the study AND have a ctDNA+ve result, are allowed to be enrolled. Patients will have central ctDNA testing, confirmed to be ctDNA+ve, and placed in Cohort B. Tumor must be documented as microsatellite stable or have intact mismatch repair proteins through CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR are excluded. The treating investigator must deem the patient a candidate for all potential agents used in this trial (5FU, LV, oxaliplatin and irinotecan). The interval between surgery (post-operative Day 7) and study entry must be no more than 60 days. Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling. Adequate hematologic function within 28 days before study entry defined as follows:
    • Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
    • Platelet count must be greater than or equal to 100,000/mm3; and
    • Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before study entry defined as follows:
    • total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
    • alkaline phosphatase must be less than 2.5 x ULN for the lab; and
    • AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before study entry defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL) HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Pregnancy test (urine or serum according to institutional standard) done within 14 days before study entry must be negative (for women of childbearing potential only). Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of INR if they are randomized to Arm 1 or Arm 3 and receive capecitabine. Eligibility Criteria for Cohort A Arm-2 patients on Second Randomization Patient must have developed a ctDNA +ve assay during serial monitoring. Patient's willingness to be re-randomized affirmed. The patient must continue to have an ECOG performance status of 0 or 1. No radiographic evidence of overt metastatic disease. Pregnancy test (urine or serum according to institutional standard) done within 14 days before study entry must be negative (for women of childbearing potential only). Adequate hematologic function within 28 days before randomization defined as follows:
    • Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
    • Platelet count must be greater than or equal to 100,000/mm3; and
    • Hemoglobin must be greater than or equal to 9 g/dL. Adequate hepatic function within 28 days before randomization defined as follows:
    • total bilirubin must be less than or equal to ULN (upper limit of normal) for the lab and
    • alkaline phosphatase must be less than 2.5 x ULN for the lab; and
    • AST and ALT must be less than 2.5 x ULN for the lab. Adequate renal function within 28 days before randomization defined as serum creatinine less than or equal to 1.5 x ULN for the lab or measured or calculated creatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels greater than 1.5 x ULN for the lab. For Women Creatinine Clearance (mL/min) = (140 - age) x weight (kg) x 0.85 72 x serum creatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 x serum creatinine (mg/dL)

    Exclusion Criteria:

      Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.). Pathologic, clinical, or radiologic overt evidence of metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected. Tumor-related bowel perforation. History of prior invasive colon malignancy, regardless of disease-free interval. History of bone marrow or solid organ transplantation (regardless of current immunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants and organ/tissue donation are not exclusionary. Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas for which treatment with neoadjuvant chemotherapy and/or radiation is warranted are not permitted). Other invasive malignancy within 5 years before study entry. Exceptions are colonic polyps, non-melanoma skin cancer or any carcinoma-in-situ. Synchronous primary rectal and/ or colon cancers. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Sensory or motor neuropathy greater than or equal to grade 2, according to CTCAE v5.0. Blood transfusion within two weeks before collection of blood for central ctDNA testing. Active seizure disorder uncontrolled by medication. Active or chronic infection requiring systemic therapy. Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency. Patients known to have Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism. Pregnancy or lactation at the time of study entry. Co-morbid illnesses or other concurrent disease that would make the patient inappropriate for entry into this study (i.e., unable to tolerate 6 months of combination chemotherapy or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens or prevent required follow-up). Ineligibility Criteria for Cohort A Arm-2 patients on Second Randomization Pregnancy or lactation at the time of randomization. No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in the opinion of the treating investigator.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • PERitoneal Carcinomatosis LEveraging ctDNA guided treatment Study in GI Cancer (PERICLES Study). - NCT04929015

    1. To measure changes in ctDNA in patients with PC from GI cancers who are candidates for Cytoreductive Surgery (CRS) with or without hyperthermic intraperitoneal chemotherapy (HIPEC). 2. To determine the clearance rate of ctDNA after complete CRS. 3. To identify any associations between clinical staging of CRS and measurable ctDNA. 4. To assess changes in ctDNA levels in response to chemotherapy in patients with PC. 5. To guide treatment based on ctDNA response.

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    • Protocol Number:
      072013

    • Principal Investigator:
      Henry Richard Alexander

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Unknown Sites,Ill-Defined Sites,Colon,Esophagus,Stomach,Rectum,Pancreas,Other Digestive Organ,Small Intestine

    • Therapies Involved:
      Therapy (NOS)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Henry Richard Alexander M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients with histologically confirmed carcinoma of presumed gastrointestinal origin (gastric, esophageal, colorectal, appendiceal, hepatobiliary or peritoneal carcinomatosis of apparent GI primary) with documented diffuse peritoneal carcinomatosis, either by conventional imaging studies, positive ascitic fluid analysis, or surgical staging
    • Measurable or evaluable disease by cross-sectional imaging studies
    • Patients must be candidates for possible surgical cytoreduction (with or without HIPEC) as determined by a study surgical oncologist
    • Age >= 18 years
    • Estimated life expectancy of at least 12 months
    • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
    • Patients must sign informed consent
    • Be willing to present for medical exams, blood draws and imaging as scheduled in protocol
    • Be able to donate two 10 mL tubes of blood every 3 months
    • Women of childbearing potential will undergo routine screening evaluation for pregnancy prior to enrollment and be managed per standard of care

    Exclusion Criteria:

    • Patients without a confirmed pathologic diagnosis of carcinoma
    • Second uncontrolled primary malignancy
    • Patients who are pregnant
    • Patients who cannot undergo a therapeutic surgical cytoreduction
    • Bone marrow transplant or other organ transplant recipient
    • Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to screening
    • Patients with cardiovascular or pulmonary risk factors contributing to high risk for surgical complications, at the discretion of the surgeon
    • Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Practices, knowledge and beliefs of colorectal cancer patients and their providers prescription practices regarding anemia and oral iron supplementation

    1) To assess the prevalence, types and dosage of oral iron supplements which oncology providers prescribe to CRC patients by reviewing CRC patients' electronic health records. 2) To determine the percentage of CRC patients diagnosed with IDA who follow through with their prescribed oral iron treatment, the amount and types of oral iron supplements which they take, factors associated with the use of oral iron supplements and their knowledge on using oral iron supplements using a patient self-report online survey. 3) To elicit the modal salient beliefs of CRC survivors underlying informed decision-making regarding oral iron supplementation via focused face-to-face interviews.

    View All Details

    • Protocol Number:
      132003

    • Principal Investigator:
      Carolyn Heckman Ph.D.

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Rectum,Colon

      • Contacts:

      • Rutgers University Prinicipal Investigator: Carolyn Heckman Ph.D.
    • Rutgers Cancer Institute of New Jersey
  • Sequential Combined TAS-102 and Oxaliplatin Alternating with TAS-102 and Irinotecan (Sequential TASOXIRI) with Bevacizumab for Late-Line Metastatic Colorectal Cancer. - NCT05806931

    The purpose of this study is to evaluate the disease control rate and time to progression of then sequential combination of oxaliplatin with an alternative anti-metabolite TAS-102 (TAS-OX) as well as irinotecan in combination with TAS-102 (TAS-IRI) + Bevacizumab in late-line metastatic colorectal cancer (mCRC).

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    • Protocol Number:
      072303

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB TAS-OX

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed stage IV colon cancer (AJCC 7th edition) that has progressed after standard therapy that included 5-FU, irinotecan, oxaliplatin and appropriate antibody therapy. Antibody therapy with bevacizumab and an anti-EGFR antibody, if RAS wild type, should have been given unless medical reasons have precluded their use. Participants who could not tolerate standard agents because of unacceptable, but reversible toxicity necessitating their discontinuation will be allowed to participate.
    • Participants who had received adjuvant chemotherapy and had recurrence during or within six months of completion of the adjuvant chemotherapy will be allowed to count the adjuvant therapy as one chemotherapy regimen for advanced disease.
    • Progression of disease must be documented on the most recent scan.
    • Presence of measurable disease
    • RAS mutation and MMR status must be determined (or tissue availability for testing if not already determined).
    • Age 18 years or older.
    • ECOG performance status 0-1.
    • Life expectancy of at least three months.
    • Participants with adequate organ function: 1. Absolute neutrophil count (ANC) > 1.5 x 109/L 2. Hemoglobin > 9 g/dL 3. Platelets (PLT) > 70 x 109/L 4. AST/ALT < 5 x ULN 5. Albumin within normal limits for institution
    • Women who are nursing and discontinue nursing prior to enrollment in the program.
    • Ability to take oral medication (i.e., no feeding tube).
    • Participant able and willing to comply with study procedures as per protocol.
    • Participant able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.

    Exclusion Criteria:

    • Participants who have previously received TAS-102.
    • Grade 3 or higher peripheral neuropathy (functional impairment).
    • Inability to tolerate irinotecan previously (due to uncontrolled diarrhea)
    • There are no specific exclusions for bevacizumab. Bevacizumab should be given unless there are specific contraindications per the treating investigator, which should be stated. If UPC is >1.0 (as above) hold bevacizumab until proteinuria resolves and then start bevacizumab.
    • Symptomatic CNS metastases requiring treatment.
    • Other active malignancy within the last three years (except for non-melanoma skin cancer or a non-invasive/in situ cancer).
    • Pregnancy or breast feeding.
    • Current therapy with other investigational agents.
    • Active infection with body temperature > 38°C due to infection.
    • Major surgery within prior four weeks (the surgical incision should be fully healed prior to drug administration).
    • Any anticancer therapy within prior two weeks of first dose of study drug.
    • History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102.
    • Current therapy with other investigational agents or participation in another clinical study or any investigational agent received within prior four weeks.
    • Grade 3 or higher hypersensitivity reaction to oxaliplatin or irinotecan, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with pre-medication.
    • Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute of New Jersey
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