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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
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Principal Investigator:
Lyudmyla Berim
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Phase:
Phase II/III
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Scope:
National
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Applicable Disease Sites:
Rectum,Colon
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Therapies Involved:
Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
Vaccine
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Drugs Involved:
IPILIMUMAB (MDX-010)
Atezolizumab (MPDL3280A)
GRT-C901
BEVACIZUMAB
GRT-R902
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Contacts:
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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
- 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.
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A Phase II Study (with Safety Run-In) of ALX148 in Combination with Cetuximab and Pembrolizumab in Patients with Refractory Microsatellite Stable Metastatic Colorectal Cancer.
- NCT05167409
Primary Objectives:
1. To determine the recommended dose (RD) of ALX148 in combination with cetuximab and pembrolizumab.
2. To determine the objective response rate (ORR), defined as partial response or complete response, with ALX148, cetuximab, and pembrolizumab using RECIST v1.1 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed on at least two lines of standard therapy.
Secondary Objectives:
1. To determine the disease-control rate (DCR), defined as stable disease, partial response, or complete response with ALX148, cetuximab, and pembrolizumab using RECIST v1.1.
2. To determine the duration of response (DOR) with ALX148, cetuximab, and pembrolizumab, defined as the time from response (partial or complete) to progression using RECIST v1.1 or death from any cause.
3. To determine the progression-free survival (PFS) with ALX148, cetuximab, and pembrolizumab, defined as the time from enrollment to the first observation of progression using RECIST v1.1 or death from any cause.
4. To determine the overall survival (OS) with ALX148, cetuximab, and pembrolizumab, defined as the time from enrollment to death from any cause.
5. To determine the first cycle dose-limiting toxicities (DLT) of ALX148, cetuximab, and pembrolizumab in stage 1.
6. To evaluate the safety and tolerability of ALX148, cetuximab, and pembrolizumab, defined and graded according to the NCI CTCAE v5.0.
View All Details
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Protocol Number:
072205
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Principal Investigator:
Patrick Boland
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Phase:
Phase II
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Scope:
National
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Applicable Disease Sites:
Colon
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
ALX148
Pembrolizumab (MK-3475)
CETUXIMAB
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Contacts:
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Rutgers University
Prinicipal Investigator:
Patrick Boland
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria: - Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease
- Have microsatellite stable disease
- Adequate hematologic and end organ function
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study: - Patients with known MSI-high status or known mismatch repair deficiency (dMMR)
- Patients in whom both mismatch repair and microsatellite stability status are unknown
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
- Left-sided (at or distal to the splenic flexure) RAS/BRAF wild-type metastatic colorectal cancer who are EGFR inhibitor naïve.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47, or anti-SIRPα agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
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.
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A Phase II Study of TAS-102, Irinotecan and Bevacizumab in Pretreated Metastatic Colorectal Cancer.
- NCT04109924
Primary: 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: Estimate the objective response rate (ORR), median overall survival (OS), and adverse event (AE) profile.
View All Details
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Protocol Number:
071914
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Principal Investigator:
Patrick Boland
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Phase:
Phase II
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Scope:
National
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Applicable Disease Sites:
Colon
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
BEVACIZUMAB
IRINOTECAN
TAS-102
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Contacts:
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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.
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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.
View All Details
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Protocol Number:
072102
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Principal Investigator:
Howard Hochster M.D
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Colon
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
CETUXIMAB
mFOLFOX6
MRTX849
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Contacts:
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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.
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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
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Protocol Number:
071807
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Principal Investigator:
Howard Hochster M.D
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Colon
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Therapies Involved:
Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
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Drugs Involved:
mFOLFOX6
Atezolizumab (MPDL3280A)
BEVACIZUMAB
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Contacts:
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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
- 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
- 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 positron emission tomography(PET)/computed tomography (CT) scan, CT scan, or magnetic resonance imaging (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 =< 1.5 x ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation > 1.5 x ULN to 3 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained within 28 days prior randomization); and
- Alkaline phosphatase must be =< 2.5 x ULN for the lab with the following exception: patients with documented liver metastases or bone involvement - alkaline phosphatase must be =< 5 x ULN (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)
- Serum creatinine =< 1.5 x ULN for the lab or measured (24 hour urine collection) or 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
- 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
- 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 14 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:
- Patients with central nervous system (CNS) metastases are excluded, with the following exceptions:
- Patients with asymptomatic untreated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following:
- Evaluable or measurable disease outside the CNS
- No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
- No history of intracranial hemorrhage or spinal cord hemorrhage
- No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.
- No neurosurgical resection or brain biopsy within 28 days prior to randomization
- Patients with asymptomatic treated CNS metastases may be enrolled, provided all eligibility criteria are met, as well as the following:
- No radiographic demonstration and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- No stereotactic radiation or whole-brain radiation within 28 days prior to randomization
- Screening CNS radiographic study >= 28 days from completion of radiotherapy and >= 14 days from discontinuation of corticosteroids
- 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 90 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
- Any of the following cardiac conditions:
- Documented New York Heart Association (NYHA) class III or IV congestive heart failure
- Myocardial infarction within 6 months prior to randomization
- Unstable angina within 6 months prior to randomization
- Symptomatic arrhythmia
- Serious or non-healing wound, skin ulcer, or bone fracture
- History of transient ischemic attack (TIA), cerebrovascular accident (CVA), gastrointestinal (GI) perforation or arterial thrombotic event within 6 months prior to randomization, symptomatic peripheral ischemia, 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
- 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
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (other than alopecia) due to agents administered more than 4 weeks earlier are excluded; however, the following therapies are allowed:
- Hormone-replacement therapy or oral contraception
- Herbal therapy > 7 days prior to randomization (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to randomization)
- Palliative radiotherapy for bone metastases > 14 days prior to randomization
- Treatment with systemic immunostimulatory medications (including, but not limited to interferon [IFN]-alpha or interleukin [IL]-2 within 42 days prior to randomization
- 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
- Patients taking bisphosphonate therapy for symptomatic hypercalcemia; use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed
- Patients requiring treatment with a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor (e.g., denosumab) who cannot discontinue it before treatment with atezolizumab
- Treatment with any other investigational agent within 4 weeks prior to randomization
- 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 HBV 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 ribonucleic acid (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, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan; 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
- Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of atezolizumab; Note: influenza vaccination should be given during influenza season only (approximately October to March); patients must not receive live, attenuated influenza vaccine within 28 days prior to randomization or at any time during the study
- Psychiatric illness/social situations that would limit compliance with study requirements
- 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 14 days prior to randomization according to institutional standards for women of childbearing potential)
- 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.
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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
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Protocol Number:
072201
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Principal Investigator:
Howard Hochster M.D
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Phase:
Phase II
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Scope:
Local
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Applicable Disease Sites:
Colon
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Therapies Involved:
Chemotherapy (NOS)
Chemotherapy multiple agents systemic
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Drugs Involved:
NBT-NM108
IRINOTECAN
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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.
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Colon Adjuvant Chemotherapy Based On Evaluation of Residual Disease (CIRCULATE-US).
- 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
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Principal Investigator:
Howard Hochster M.D
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Phase:
Phase II/III
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Scope:
National
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Applicable Disease Sites:
Colon
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Therapies Involved:
Radiotherapy
Chemotherapy (NOS)
Chemotherapy multiple agents systemic
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Drugs Involved:
CAPOX
mFOLFIRINOX
mFOLFOX6
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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.
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Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy (COLOMATE).
- NCT03765736
To perform blood-based genomic profiling on patients with treatment refractory metastatic CRC to facilitate accrual to molecularly assigned therapies. To facilitate clinically annotated genomic analyses
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
- Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)
- For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)
- Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
- At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- Life expectancy >= 3 months per estimation of investigator
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Capable of understanding and complying with the protocol requirements and has signed the informed consent document
- Satisfy at least one of the following two conditions:
- Willing and able to provide blood sample for screening purposes
- Guardant 360 testing completed =< 60 days prior to registration
Exclusion Criteria:
- Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of < 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
- Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
- History of solid organ transplantation
- Pregnant or planning to become pregnant within the next 12 months
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.
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PERitoneal Carcinomatosis LEveraging ctDNA guided treatment Study in GI Cancer (PERICLES Study).
- NCT04929015
- 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).
- To determine the clearance rate of ctDNA after complete CRS.
- To identify any associations between clinical staging of CRS and measurable ctDNA.
- To assess changes in ctDNA levels in response to chemotherapy in patients with PC.
- To guide treatment based on ctDNA response.
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Protocol Number:
072013
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Principal Investigator:
Henry Richard Alexander
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Phase:
Phase II
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Scope:
Local
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Applicable Disease Sites:
Unknown Sites,Ill-Defined Sites,Colon,Esophagus,Stomach,Rectum,Pancreas,Other Digestive Organ,Small Intestine
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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.
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Phase II Pilot Study of FOLFOXIRI plus Panitumumab in Metastatic RAS Wild-Type, Left-Sided Colorectal Cancer.
- NCT04169347
The primary objective of this study is to evaluate the efficacy/objective response rate of the combination of FOLFOXIRI and panitumumab as first-line therapy for metastatic left sided, RAS WT CRC.
Secondary objectives include evaluating PFS, OS, toxicity of this regimen, and radiographic tumor regression.
Further exploratory objectives include evaluating for the velocity of tumor response to this regimen
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Protocol Number:
071910
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Principal Investigator:
Howard Hochster M.D
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Phase:
Phase II
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Scope:
National
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Applicable Disease Sites:
Colon
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
OXALIPLATIN
PANITUMUMAB
LEUCOVORIN
IRINOTECAN
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Contacts:
-
Rutgers University
Prinicipal Investigator:
Howard Hochster M.D
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
1. Subjects must have signed an approved informed consent. 2. Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum. 3. No previous systemic chemotherapy for metastatic disease - Subjects who have had prior adjuvant chemotherapy for non-metastatic disease are eligible if more than six months have elapsed after completing therapy
- Subjects treated with adjuvant chemotherapy who relapse within six months after completion will not be eligible. 4. Bidimensionally measurable disease as defined in Section 3.3.1. 5. RAS wild-type tested in
- KRAS exon 2 (codons 12/13)
- KRAS exon 3 (codons 59/61)
- KRAS exon 4 (codons 117/146)
- NRAS exon 2 (codons 12/13)
- NRAS exon 3 (codons 59/61)
- NRAS exon 4 (codons 117/146) 6. ECOG Performance Status 0-1 (Appendix 1). 7. Recovery in full, from any previous surgical procedure. 8. Subjects >=18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the study in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication. 9. Creatinine clearance ≥ 50 ml/min or serum creatinine ≤ 1.5 x upper limit of normal. 10. Bilirubin ≤ 1.5 x upper limit of normal 11. AST, ALT ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases, 12. Albumin within normal institutional limits 13. Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal . 14. Absolute Neutrophil Count > 1500/mm3 and platelets > 100,000/mm3.
Exclusion Criteria:
1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 months after the study. Subjects who are men must also agree to use effective contraception. 2. Women who are pregnant or breastfeeding. 3. Women with a positive pregnancy test on enrollment or prior to study drug administration. 4. Subjects with >grade 1 neuropathy except for loss of tendon reflex. 5. Any active or uncontrolled infection. 6. Clinically significant cardiovascular disease (myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrollment 7. Past or current history of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin
- In-situ carcinoma of the cervix
- Other malignant disease without recurrence after at least 3 years of follow-up 8. History or evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumor, seizure not controlled with standard medical therapy, brain metastases or history of stroke). 9. Clinically relevant interstitial lung disease (pneumonitis, pulmonary fibrosis, evidence of interstitial lung disease on baseline chest CT scan) 10. Allogeneic transplantation requiring immunosuppressive therapy. 11. Severe non-healing wounds, ulcers or bone fractures. 12. Evidence of bleeding diathesis or coagulopathy. 13. Patients not receiving therapeutic anticoagulation must have an INR < 1.5 x ULN and aPTT < 1.5 x ULN within 7 days prior to randomization. The use of full-dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks. 14. Concomitant therapy with certain anti-viral medicines (sorivudine and brivudine or analogue compounds). 15. Major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration. 16. Subjects with known allergy to the study drugs or to any of its metabolites. 17. Known DPD deficiency. 18. Current or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. 19. Known grade III/IV allergic reaction against monoclonal antibodies. 20. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
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.
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Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA).
- NCT04068103
Primary Objectives:
1.1.1 Primary Objective Phase II
To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer.
1.1.2 Primary Objective Phase III
To compare recurrence-free survival (RFS) in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer.
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Protocol Number:
071915
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Principal Investigator:
Patrick Boland
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Phase:
Phase II/III
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Scope:
National
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Applicable Disease Sites:
Colon
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
CAPECITABINE
LEUCOVORIN
OXALIPLATIN
FLUOROURACIL
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Contacts:
-
Rutgers University
Prinicipal Investigator:
Patrick Boland
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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically/pathologically confirmed stage IIA adenocarcinoma of the colon (T3, N0, M0) with at least 12 lymph nodes examined at the time of surgical resection.
- Appropriate for active surveillance (i.e., no adjuvant chemotherapy) at the discretion of and as documented by the evaluating oncologist based on current practice patterns.
- The distal extent of the tumor must be >= 12 cm from the anal verge on pre-surgical endoscopy (i.e., excluding rectal adenocarcinomas warranting treatment with chemoradiation). If the patient did not undergo a pre-surgical endoscopy, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination or pre-operative imaging.
- The patient must have had an en bloc complete gross resection of tumor (curative resection) as definitive surgical cancer treatment within 14 to 60 days of study randomization. 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.
- Availability and provision of adequate surgical tumor tissue for molecular diagnostics and confirmatory profiling.
- Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 28 days before randomization).
- Platelet count must be >= 100,000/mm^3 (within 28 days before randomization); and
- Hemoglobin must be >= 9 g/dL (within 28 days before randomization).
- Total bilirubin must be =< ULN (upper limit of normal) for the lab (within 28 days before randomization) unless the patient has a chronic grade 1 bilirubin elevation due to Gilbert?s disease or similar syndrome involving slow conjugation of bilirubin; and
- Alkaline phosphatase must be < 2.5 x ULN for the lab (within 28 days before randomization); and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 1.5 x ULN for the lab (within 28 days before randomization).
- Serum creatinine =< 1.5 x ULN for the lab or measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 28 days before randomization).
- Pregnancy test (urine or serum according to institutional standard) done within 14 days before randomization must be negative (for women of childbearing potential only).
- Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring of international normalized ratio (INR) if they are randomized to Arm 2 and receive capecitabine.
Exclusion Criteria:
- Colon cancer histology other than adenocarcinoma (i.e., neuroendocrine carcinoma, sarcoma, lymphoma, squamous cell carcinoma, etc.).
- Pathologic, clinical, or radiologic evidence of overt metastatic disease. This includes isolated, distant, or non-contiguous intra-abdominal metastases, even if resected (including the presence of satellite nodules constituting N1c disease in the absence of lymph node involvement).
- Tumor-related bowel perforation.
- History of prior invasive colon malignancy, regardless of disease-free interval.
- History of organ transplantation.
- Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer (e.g., primary rectal adenocarcinomas for which treatment with neoadjuvant chemoradiation is warranted are not permitted).
- Other invasive malignancy within 5 years before randomization. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ including those of the cervix and breast (DCIS).
- Synchronous primary rectal and/or colon cancers.
- Antineoplastic therapy (e.g., chemotherapy, targeted therapy, or immunotherapy) within 5 years before randomization. (For the purposes of this study, hormonal therapy is not considered chemotherapy.).
- Uncontrolled cardiac disease, in the opinion of the treating medical oncologist, that would preclude the use of any of the drugs included in the GI005 treatment regimen. This includes but is not limited to:
- Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker.
- Ventricular tachycardia or supraventricular tachycardia that requires treatment with class Ia antiarrhythmic drugs (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide). Use of other antiarrhythmic drugs is permitted.
- Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker.
- Complete left bundle branch block (LBBB) unless treated with a permanent pacemaker.
- Sensory or motor neuropathy >= grade 2, according to Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
- Active seizure disorder uncontrolled by medication.
- Active or chronic infection requiring systemic therapy.
- Known homozygous DPD (dihydropyrimidine dehydrogenase) deficiency.
- Pregnancy or lactation at the time of randomization.
- Co-morbid illnesses or other concurrent disease that, in the judgement of the clinician obtaining informed consent, 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).
- Prior testing with any available ctDNA test as part of the management of colon cancer, is not permitted.
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.
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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.
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