10 results
  • A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma (FLORA-5) - NCT04498117

    Primary: To determine the efficacy by progression free survival (using investigator assessment of scans according to RECIST v1.1) of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery Secondary: To determine the efficacy by overall survival of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery. To assess the safety and tolerability of oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) to subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery. To evaluate the effects of treatment with oregovomab compared to placebo when administered with background chemotherapy (paclitaxel/carboplatin) on Health-related Quality of Life(HRQoL) as assessed by trial outcome index (TOI) of the Functional Assessment of Cancer Therapy Ovarian (FACT-O) and 3 additional questions from the NFOSI-18 in subjects with newly diagnosed ovarian cancer (FIGO Stage III or IV) who have undergone optimal debulking surgery.

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    • Protocol Number:
      102103

    • Principal Investigator:
      Aliza Leiser

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital,Ovary

    • Therapies Involved:
      Surgery Chemotherapy single agent systemic

    • Drugs Involved:
      Oregovomab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Aliza Leiser

    Read Inclusion & Exclusion Criteria

    Major Inclusion Criteria:

      1. Adults 18 years old or older. 2. Newly diagnosed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin FIGO Stage III or IV disease. 3. Histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.). 4. Completed debulking surgery (either primary debulking surgery or interval debulking surgery at the discretion of the investigator). Debulking surgery must be optimal, R1 or R0 (defined as R1, macroscopic no greater than 1 cm in diameter, or R0, microscopic or no evidence of tumor). 5. Preoperative serum CA- 125 levels ≥ 50 U/mL. 6. Adequate bone marrow function: 1. Absolute neutrophil count (ANC) greater than or equal to 1,500/µL 2. Platelets greater than or equal to100,000/µL 3. Hemoglobin greater than or equal to 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment). 7. Adequate liver function: 1. Bilirubin < 1.5 times upper limit normal (ULN) 2. Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN 3. Albumin >3.5 g/dL 8. Adequate renal function: a. Creatinine less than or equal to1.5 times ULN 9. ECOG Performance Status of 0 or 1.

    Major Exclusion Criteria:

      1. BRCA1 or BRCA2 germline gene mutation test result with: 1. Positive, ambiguous or inconclusive result available within 28 days prior to starting study treatment, or 2. Known BRCA1 and BRCA2 somatic mutations, and known positive germline, or 3. Somatic Homologous Recombination Deficiency (HRD) who will receive PARP inhibitor front-line maintenance therapy. 2. Subjects with mucinous adenocarcinoma and low- grade adenocarcinoma. 3. Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment (C1D1 for Cohort 1 or C4D1 for Cohort 2). 4. Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment. 5. Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab, paclitaxel, or carboplatin. 6. Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc. (see Appendix G). 7. Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper. (Note: Premedication with corticosteroids per institutional standard of care is allowed.) 8. Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia. 9. Anticipated treatment with any other anti-cancer medications, including bevacizumab, poly (ADP- ribose) polymerase (PARP) inhibitors, or any investigational agent(s) during the study.

    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 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer. - NCT04729608

    Primary Objective To evaluate the effect of AVB-S6-500 (AVB) plus PAC (AVB-S6-500 + PAC) versus Placebo and PAC (Placebo + PAC) on PFS based on RECIST v1.1 criteria, in subjects with platinum-resistant recurrent ovarian cancer. Secondary Objectives To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on OS To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on ORR based on RECIST v1.1 criteria To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on duration of response (DOR) based on RECIST v1.1 criteria To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on quality of life (QOL) as assessed by the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) questionnaire To evaluate the effect of AVB-S6-500 + PAC versus Placebo + PAC on clinical benefit rate (CBR) based on RECIST v1.1 criteria The safety objectives of the study are: To evaluate the safety and tolerability of AVB-S6-500 + PAC versus Placebo + PAC To evaluate the immunogenicity of AVB-S6-500 Exploratory Objectives The exploratory objectives of the study are to evaluate effect of AVB-S6-500 + PAC versus Placebo + PAC in serum on additional efficacy parameters and may include the following: Cancer antigen 125 (CA-125) levels Biomarkers (e.g., AXL, soluble AXL, and GAS6)

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    • Protocol Number:
      102102

    • Principal Investigator:
      Aliza Leiser

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      AVB-S6-500 PACLITAXEL

      • Contacts:

      • Rutgers University Prinicipal Investigator: Aliza Leiser

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
    • Aged 18 years or older
    • Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
    • Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
    • Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
    • Received at least 1 but not more than 4 prior therapy regimens. Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy. Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.
    • Measurable disease according to RECIST v1.1 criteria
    • Normal gastrointestinal function.
    • At least 28 days between termination of prior anticancer or hormonal therapy and first administration of AVB-S6-500.
    • Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.

    Exclusion Criteria:

    • Tumors in the breast or bone
    • Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
    • Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
    • Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
    • Received prior therapy with PAC in the platinum-resistant recurrent setting
    • Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of AVB-S6-500/placebo

    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.

    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • AGCT1531: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors. - NCT03067181

    The aim of this study for low and standard risk germ cell tumor (GCT) patients is to minimize toxicity by reducing therapy while maintaining current survival rates. The trial will eliminate chemotherapy for low risk patients who are likely cured with surgery and will observe the salvage rates among those who recur.

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    • Protocol Number:
      111702

    • Principal Investigator:
      Archana Sharma DO

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Prostate,Ovary

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BLEOMYCIN CARBOPLATIN CISPLATIN ETOPOSIDE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Archana Sharma DO

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites])
    • Standard risk 1: Patient must be < 11 years of age at enrollment
    • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
    • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
    • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; all ages
    • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
    • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
    • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11
    • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25
    • Notes:
    • IGCCC criteria only apply to SR2 patients with a testicular primary tumor
    • Use post-op tumor marker levels to determine IGCCC risk group
    • Stage 1 seminoma patients are not eligible for the standard risk arms of the study
    • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
    • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
    • Adequate renal function defined as:
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 OR
    • A serum creatinine based on age/gender as follows: (mg/dL)
    • 1 month to < 6 months male: 0.4 female: 0.4
    • 6 months to < 1 year male: 0.5 female: 0.5
    • 1 to < 2 years male: 0.6 female: 0.6
    • 2 to < 6 years male: 0.8 female: 0.8
    • 6 to < 10 years male: 1 female: 1
    • 10 to < 13 years male: 1.2 female: 1.2
    • 13 to < 16 years: male: 1.5 female: 1.4
    • >= 16 years male: 1.7 female: 1.4
    • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
    • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L)
    • Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 AND
    • Platelet count >= 100,000/mm^3
    • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
    • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
    • >= 11 and < 25 years old at enrollment
    • Able to fluently speak and read English
    • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
    • Followed for cancer or survivorship care at one of the following institutions:
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    • Dana Farber/Harvard Cancer Center
    • Hospital for Sick Children
    • Children's Hospital of Eastern Ontario
    • Oregon Health and Science University
    • Seattle Children's Hospital
    • Yale University

    Exclusion Criteria:

    • Patients with any diagnoses not listed including:
    • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
    • Pure dysgerminoma
    • Pure mature teratoma
    • Pure immature teratoma COG stage I, grade I
    • Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) >= 1000 ng/mL
    • Pure immature teratoma COG stage II - IV or FIGO stage IC to IV
    • "Poor risk" GCT (age >= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or
    • Primary central nervous system (CNS) germ cell tumor
    • Germ cell tumor with somatic malignant transformation
    • Spermatocytic seminoma
    • Patients must have had no prior systemic therapy for the current cancer diagnosis
    • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial)
    • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients])

    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
    • Rutgers Cancer Institute of New Jersey
  • Cancer treatment and survivorship experiences among Southern New Jersey residents.

    The primary objective of this project is to conduct a survey of cancer survivors to understand cancer burden, treatment outcomes, care needs, cancer prevention practices, health care access, and health information seeking behaviors of persons living in Southern New Jersey (Atlantic, Burlington, Camden, Cape May, Cumberland, Gloucester, Mercer, Ocean, and Salem counties). To date, health needs of cancer survivors who are residents of these Southern New Jersey counties remain largely unexplored. Specific Aim 1: To determine the feasibility of conducting research on the access and needs of patients diagnosed with cancers who reside in the New Jersey counties outlined. Specific Aim 2: To characterize the cancer burden, quality of life characteristics, care needs, cancer prevention practices, health care access, survivorship care experiences, cancer surveillance, and health information seeking behaviors of patients diagnosed with cancers who reside in the New Jersey counties outlined.

    View All Details
    • Protocol Number:
      131803

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon,Breast - Female,Melanoma, Skin,Ovary,Lung,Rectum,Cervix,Other Female Genital,Thyroid,Prostate,Urinary Bladder

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey
  • COG AGCT 1532: Phase 3 Accelerated BEP Trial:A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumours. - NCT02582697

    1. To determine if accelerated BEP (Bleomycin, Etoposide, cisPlatin) is superior to standard BEP as first-line chemotherapy for intermediate and poor-risk metastatic GCTs. 2. To compare the two treatment arms with respect to: a) Progression-free survival (disease progression or death) b) Response following treatment completion (protocol-specific response criteria) c) Adverse events (worst grade according to NCI CTCAE v4.03) d) Delivered dose-intensity of chemotherapy (Relative to standard BEP) e) Overall survival (death from any cause)

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    • Protocol Number:
      111904

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital,Other Male Genital

      • Contacts:

      • Rutgers University Prinicipal Investigator: Richard Drachtman M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Age ≥ 11 years and ≤ 45 years on the date of randomisation 2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently 3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum 4. Metastatic disease or non-testicular primary 5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information). 6. Adequate bone marrow function with ANC ≥1.0 x 10^9/L, Platelet count ≥100 x 10^9/L 7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN 8. Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be < 60 ml/min or borderline in which case GFR should be formally measured, eg. with EDTA scan 9. ECOG Performance Status of 0, 1, 2, or 3 10. Study treatment both planned and able to start within 14 days of randomisation. 11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments 12. Able to provide signed, written informed consent

    Exclusion Criteria:

      1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence) 2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient has non-seminoma and poor prognosis by IGCCC criteria in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). In these instances acceptable regimens include cisplatin 20 mg/m^2 days 1-2 and etoposide 100 mg/m^2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg/m^2 days 1-2; or baby-BOP. Patients must meet all other inclusion and exclusion criteria at the time of registration. Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy. 3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin 4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin 5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus 6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety 7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy. 8. Known allergy or hypersensitivity to any of the study drugs 9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse The above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.

    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
  • NRG-CC008: A Non-randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among Brca1 Carriers [SOROCK]. - NCT04251052

    Primary Objective: - To compare the non-inferiority of bilateral salpingectomy (BLS) with delayed oophorectomy to bilateral salpingo-oophorectomy (BSO) to reduce the risk of ovarian cancer among women with deleterious BRCA1 germline mutations. Secondary Objectives: - To prospectively assess estrogen deprivation symptoms in BLS patients as measured by the FACT-ES subscale compared to women in the BSO arm. To determine if health-related QOL (FACT) is negatively impacted by menopausal symptoms (menopausal symptom checklist-MSCL), sexual dysfunction (FSFI), and cancer distress (IES) in women who have undergone BLS, in comparison to normative data (MSCL/FACT-ES) and data from BSO patients. - To assess medical decision making, as measured by the Shared Decision Making Questionnaire (SDM-Q-9) and Decision Regret Scale (DRS), and determine factors associated with the risk of reducing surgical treatment choice. - To assess adverse events, graded using CTCAE v5.0.

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    • Protocol Number:
      102005

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Women 35-50 years of age, inclusive
    • Patients who have declined or elected to defer risk-reducing salpingo-oophorectomy (RRSO) after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm)
    • At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and tube are present
    • Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required
    • Premenopausal; defined as < 12 months of amenorrhea. However, for those patients with >= 12 months of amenorrhea who may be pre-menopausal or patients with a prior hysterectomy with at least one retained ovary/tube, levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and in the premenopausal range per local institutional standards will be acceptable. Concurrently planned hysterectomy with salpingectomy for the BS group or with BSO for the BSO group is permitted
    • Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

    Exclusion Criteria:

    • Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time
    • Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma
    • Patients medically unfit for the planned surgical procedure
    • Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days
    • An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary)
    • An abnormal CA-125 is defined as a level > 50 U/ml in this study population of premenopausal women if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal women who are current users of oral contraceptives
    • Women who are currently pregnant or plan to become pregnant in the future

    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.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute of New Jersey
  • NRG-GY006: A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or In Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, or Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer. - NCT02466971

    To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase progression-free survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer.

    View All Details
    • Protocol Number:
      101909

    • Principal Investigator:
      Lara Hathout MD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Cervix,Other Female Genital

    • Therapies Involved:
      Chemotherapy single agent systemic Radiotherapy

    • Drugs Involved:
      TRIAPINE CISPLATIN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Lara Hathout MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone; the presence or absence of para-aortic lymph node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline 18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG PET/CT scan
    • Patient must provide study specific informed consent prior to study entry
    • Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2 or equivalent
    • Absolute neutrophil count > 1,500/uL
    • Platelets > 100,000/uL
    • Hemoglobin > 10 g/dL
    • Total bilirubin < 2.0 mg/dL
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
    • Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X institutional upper limit of normal
    • Creatinine =< 1.5 mg/dL to receive weekly cisplatin
    • Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the purpose of estimating the CCr, the formula of Cockcroft and Gault for females should be used
    • Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose > 200 mg/dL)
    • Patient has a life expectancy of greater than 20 weeks
    • Patient does not have known brain metastases (testing optional)
    • Patient does not have known human immunodeficiency virus syndrome (HIV, testing optional); known HIV-positive patients receiving combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with triapine
    • Patient does not have a known allergy to compounds of similar or biologic composition as triapine
    • Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the condition interferes with triapine antidote metabolism (G6PD testing optional)
    • Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding before the initiation of protocol therapy)

    Exclusion Criteria:

    • Patient has another concurrent active invasive malignancy
    • Patient has had a prior invasive malignancy diagnosed within the last three years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix); patients are excluded if they have received prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues at the discretion of the treating physician
    • Patient has uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within six months of protocol initiation, cardiac arrhythmia within six months of protocol initiation; known inadequately controlled hypertension; clinically significant pulmonary disease including dyspnea at rest, or patients requiring supplemental oxygen, or poor pulmonary reserve; or clinically significant renal function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric illness/social situations that would limit compliance with study requirements
    • Patient is receiving another investigational agent for the treatment of cancer
    • Patient is currently pregnant
    • Patient does not agree to use two forms of birth control if they are of child-bearing potential
    • Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy following radiation as part of their cervical cancer treatment are ineligible (05/30/2017)
    • Patients scheduled to be treated with adjuvant consolidation chemotherapy or other anti-neoplastic therapy at the conclusion of their standard chemoradiation (05/30/2017)
    • Patients with self-reported or known diagnosis of G6PD deficiency (05/30/2017)
    • Patients with vaginal cancer may have previously undergone a hysterectomy for various indications; patients with vaginal cancer who underwent a hysterectomy for treatment of cervical cancer less than five years prior to their diagnosis of vaginal cancer are ineligible

    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
  • NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer. - NCT03914612

    To evaluate the efficacy of pembrolizumab in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer. Efficacy will be determined via investigator assessed progression free survival (PFS) in two distinct populations referred to as proficient and deficient mismatch repair (pMMR and dMMR).

    View All Details
    • Protocol Number:
      101910

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      PACLITAXEL CARBOPLATIN pembrolizumab/placebo

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
    • Pathology report showing results of institutional MMR IHC testing.
    • Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.).
    • Submission of tumor specimens for centralized MMR IHC testing is required after Step 1 and before Step 2 registration.
    • In patients with measurable disease, lesions will be defined and monitored by RECIST version (v) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be >= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be >= 15 mm in short axis when measured by CT or MRI.
    • Patients may have received
    • NO prior chemotherapy for treatment of endometrial cancer OR
    • Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed >= 12 months prior to STEP 2 registration.
    • Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to STEP 2 registration.
    • Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted.
    • Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to STEP 2 registration.
    • Age >= 18
    • Performance status of 0, 1 or 2.
    • Platelets >= 100,000/mcl.
    • Absolute neutrophil count (ANC) >= 1,500/mcl.
    • Creatinine =< 1.5 x institutional/laboratory upper limit of normal (ULN).
    • Total serum bilirubin level =< 1.5 x upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled).
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN.
    • Thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal range despite no symptoms of thyroid dysfunction, normal Free T4 level is required.
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 2 registration are eligible for this trial.
    • For patients of child bearing potential: negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.
    • Administration of study drugs (pembrolizumab, paclitaxel, carboplatin) may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from at least 14 days prior to Step 2 registration (for oral contraceptives), during treatment, and for 120 days after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients will be considered of nonreproductive potential if they are either:
    • Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR
    • Have a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to Step 2 registration; OR
    • Have a congenital or acquired condition that prevents childbearing.
    • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.

    Exclusion Criteria:

    • Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
    • Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients; and/or a severe hypersensitivity reaction to paclitaxel and/or carboplatin
    • Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to Step 2 registration.
    • Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Step 2 registration.
    • Patients who have received steroids as CT scan contrast premedication may be enrolled.
    • The use of inhaled or topical corticosteroids is allowed.
    • The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
    • The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.
    • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, and they have been off steroids for at least 4 weeks prior to Step 2 registration and remain clinically stable.
    • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
    • Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
    • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
    • Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
    • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis.
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
    • Pregnant or lactating patients.

    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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • Trial of Maintenance with Niraparib in patients with stage III, stage IV or platinum-sensitive Recurrent Uterine Serous Carcinoma - NCT04080284

    Primary Objective: To determine the Progression Free Survival (PFS) at 1 year in the proposed Niraparib regimen in the population of patients with stage III, all stage IV, or recurrent uterine serous carcinoma (USC). Secondary Objectives: 1. Progression-free survival (PFS), Overall Survival (OS), Overall response rate (ORR) at 2, and 3 years interval from start of treatment protocol. 2. To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in patients with stage III, all stage IV, or recurrent uterine serous carcinoma (USC). 3. To identify the prevalence of somatic mutations, HRD mutations, and overall mutational burden in patients with USC and classify tumor into loss of heterozygosity (LOH) high and low phenotype. 4. To evaluate quality of life (QOL) for the subjects undergoing this treatment, using validated tools. QOL will be assessed every 3 months during treatment course.

    View All Details
    • Protocol Number:
      102101

    • Principal Investigator:
      Eugenia Girda Assistant

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Other Female Genital

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Niraparib

      • Contacts:

      • Rutgers University Prinicipal Investigator: Eugenia Girda Assistant Professor GYN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Female, age at least 18 years 2. ECOG performance status of <2 3. Written voluntary informed consent 4. Histologically diagnosed Uterine Serous Carcinoma. 5. Patient must agree to undergo Foundation One testing. 6. Patient diagnosed with advanced stage USC including stage III, stage IV, or platinum-sensitive recurrent USC 7. If recurrent USC, patient must have platinum sensitive disease after initial treatment; defined as achieving a response (CR or PR) and disease progression >6 months after completion of their last dose of platinum chemotherapy. 8. Patients eligible if receiving 1st or 2nd line chemotherapy for recurrence. 9. The patient must have achieved a partial, stable, or complete tumor response following the last chemotherapy (minimal of 3 cycles) regimen of physician choice chemotherapy indicating partial, stable, complete tumor response. 10. Patients must receive Niraparib maintenance within 12 weeks after completion of their final dose of chemotherapy regimen or within 14 weeks if received radiation therapy. CT Chest/Abd/Pelvis will be performed within 28 days of starting Niraparib. 11. Lesions can be non-measurable or measurable by RECIST 1.1 criteria. 12. Adequate organ function, defined as: 1. Absolute neutrophil count ≥ 1,500/μL 2. Platelets ≥ 100,000/μL 3. Hemoglobin ≥ 9 g/dL 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation 5. Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN 6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN 13. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy. 14. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment. 15. Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of non childbearing potential. Non childbearing potential is defined as follows (by other than medical reasons): 1. ≥45 years of age and has not had menses for >1 year Patients who have been amenorrhoeic for <2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. See Section 6.4 for a list of acceptable birth control methods. Information must be captured appropriately within the site's source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient. 2. Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment. 3. Able to take oral medications.

    Exclusion Criteria:

    • 1. Participant must not be simultaneously enrolled in any interventional clinical trial 2. Drainage of ascites during the last 2 cycles of last chemotherapy 3. Radiotherapy was given within 2 weeks encompassing >20% of the bone marrow or any radiation therapy within one week prior to Day 1 of protocol therapy. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior to initiating protocol therapy. 4. Persistent >Grade 2 anemia, neutropenia, or thrombocytopenia from prior cancer therapy, that has persisted > 4 weeks and was related to the most recent treatment. 5. Symptomatic uncontrolled brain or leptomeningeal metastases. 6. Known hypersensitivity to the components of Niraparib 7. Major surgery within 3 weeks of starting the study or patient has not recovered from any effects of any major surgery 8. Diagnosis, detection, or treatment of invasive cancer other than uterine cancer

    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
  • Web-Based Coping and Communication Skills Intervention for Women who are newly diagnosed with Gynecological Cancer: A Pilot Study.

    1) To collect feedback from patients on CCI online and to assess patients evaluation to CCI online 2) To examine the feasibility and acceptability of a CCI online 3) To collect pilot data on the impact of CCI online on depression, anxiety, cancer-specific distress, fear of recurrence, and psychological well-being, as well as on coping efficacy and coping skills

    View All Details
    • Protocol Number:
      131908

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Ovary,Cervix

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey