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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.

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    • Protocol Number:
      071807

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

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

    • Drugs Involved:
      Atezolizumab (MPDL3280A) mFOLFOX6 BEVACIZUMAB

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • RWJ University Hospital Hamilton
    • Rutgers Cancer Institute
  • 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.

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    • Protocol Number:
      072201

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon

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

    • Drugs Involved:
      NBT-NM108 IRINOTECAN

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Biopsy proven and metastatic colon cancer
    • Candidate for Second-line or later line therapy with irinotecan-based chemotherapy regimen with starting dose of irinotecan at 180 mg/m2 q2w.Participants who have had prior irinotecan will be eligible if they are off irinotecanfor 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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • Robert Wood Johnson University Hospital
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
    • Trinitas Regional Medical Center – Williamson Street Campus
  • Choices About Genetic Testing And Learning Your Risk with Smart Technology (CATALYST) - NCT06184867

    The study's objectives are to: 1) finalize the development and optimize usability of the CATALYST digital intervention (i.e., RA also known as relational assistant (RA)); 2) evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery in cancer survivors. Participants will be randomized to one of two study arms which are the RA intervention vs. enhanced usual care (EUC); and 3) Conduct a process evaluation to measure barriers/facilitators to GC, GT and use of the CATALYST intervention and engagement with the RA.

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    • Protocol Number:
      132307

    • Principal Investigator:
      Anita Kinney PhD,RN

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Pancreas,Other Female Genital,Prostate,Colon,Ovary,Breast

      • Contacts:

      • Rutgers University Prinicipal Investigator: Anita Kinney PhD,RN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • User/Usability Testing 1. Age 18 or older 2. Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer 3. Speak/read and understand English 4. Capable of providing informed consent 5. Have Internet access (via smartphone, tablet, or computer)
    • Feasibility Randomized Trial 1. Age 18 or older 2. Diagnosed with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, colorectal cancer, breast cancer at age 50 or below or triple negative breast cancer at age 60 or below, pancreatic cancer, or endometrial cancer at age 50 or below, regional/metastatic/intraductal prostate cancer or prostate cancer with a Gleason score ≥7 per NCCN guidelines 3. Speak/read and understand English 4. Capable of providing informed consent 5. Have Internet access (via smartphone, tablet or computer) 6. Have not previously undergone GT for hereditary cancer predisposition

    Exclusion Criteria:

    • Participants will be 18 years of age or older because germline genetic testing is generally not recommended in children when the test results would not impact clinical management. Participants from the user and usability testing phases are not eligible to participate in the feasibility 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.

    • Rutgers Cancer Institute
  • Colon Adjuvant Chemotherapy Based On Evaluation of Residual Disease. - NCT05174169

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

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    • Protocol Number:
      072207

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Colon

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

    • Drugs Involved:
      CAPOX mFOLFIRINOX mFOLFOX6

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      The patient must have an ECOG performance status of 0 or 1.Patients must have histologically/pathologically confirmed Stage IIB, IIC, or Stage IIIcolon adenocarcinoma with R0 resection according to AJCC 8th edition criteria.No radiographic evidence of overt metastatic disease within 45 days prior to Step 1/Studyentry (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 vergeon colonoscopy or above the peritoneal reflection as documented during surgery or onpathology specimen (i.e., excluding rectal adenocarcinomas warranting treatment withchemoradiation).The patient must have had an en bloc complete gross resection of tumor (curativeresection). Patients who have had a two-stage surgical procedure, to first provide adecompressive colostomy and then in a later procedure to have the definitive surgicalresection, are eligible.The resected tumor specimen and a blood specimen from patients with Stage IIB, IIC, orStage III colon cancer must have central testing for ctDNA using the Signatera™ assay byNatera (after Step 1/Study entry and before Step2/Randomization). Patient must havesufficient tissue to meet protocol requirements. This blood specimen for the Signateraassay must be collected after surgery (and recommended at least 14 days post surgery).Tumor must be documented as microsatellite stable or have intact mismatch repair proteinsthrough CLIA-approved laboratory testing. Patients whose tumors are MSI-H or dMMR areexcluded.The treating investigator must deem the patient a candidate for all potential agents usedin this trial (5FU, LV, oxaliplatin and irinotecan).The interval between surgery (post-operative Day 7) and Step 1/Study entry must be nomore than 60 days. NOTE: Step 1/Study Entry may occur as early as post operative Day 7,but it cannot occur beyond 60 days from the actual date of the patient's surgery.Availability and provision of adequate surgical tumor tissue for molecular diagnosticsand confirmatory profiling.Adequate hematologic function within 28 days before Step 1/Study entry defined asfollows:
    • Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
    • Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
    • BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
    • 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 Step 1/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 Step 1/Study entry defined as serumcreatinine less than or equal to 1.5 x ULN for the lab or measured or calculatedcreatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formulafor 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 serumcreatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 xserum creatinine (mg/dL) NOTE: Adjusted body weight (AdjBW) should be used for patientsthat have BMI greater than or equal to 28 (less than or equal to 30% above IBW).HIV-infected patients on effective anti-retroviral therapy with undetectable viral loadwithin 6 months are eligible for this trial.Pregnancy test (urine or serum according to institutional standard) done within 14 daysbefore Step 1/Study entry must be negative (for women of childbearing potential only).Patients receiving a coumarin-derivative anticoagulant must agree to weekly monitoring ofINR if they are randomized to Arm 1 or Arm 3 and receive capecitabine.Eligibility Criteria for Cohort A Arm-2 patients on Second RandomizationPatient 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 daysbefore second randomization must be negative (for women of childbearing potential only).Adequate hematologic function within 28 days before second randomization defined asfollows:
    • Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
    • Participants with benign ethnic neutropenia (BEN): ANC less than 1300 mm3 are eligible.
    • BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.
    • 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 second 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 second randomization defined as serumcreatinine less than or equal to 1.5 x ULN for the lab or measured or calculatedcreatinine clearance greater than or equal to 50 mL/min using the Cockroft-Gault formulafor 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 serumcreatinine (mg/dL) For Men Creatinine Clearance (mL/min) = (140 - age) x weight (kg) 72 xserum 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 includesisolated, 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 currentimmunosuppressive therapy needs). Bone grafts, skin grafts, corneal transplants andorgan/tissue donation are not exclusionary.Any prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapyadministered as treatment for colorectal cancer (e.g., primary colon adenocarcinomas forwhich treatment with neoadjuvant chemotherapy and/or radiation is warranted are notpermitted). EXCEPTION: one cycle of chemotherapy (regimen per treating physicians'discretion - 5-FU or capecitabine with or without oxaliplatin) is allowed but notrequired after consent. The optional cycle of chemotherapy should be started greater thanor equal to 4 weeks from surgery and while awaiting Step 2 randomization.Other invasive malignancy within 5 years before Step 1/Study entry. Exceptions arecolonic 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 oftreatment with cardiotoxic agents, should have a clinical risk assessment of cardiacfunction using the New York Heart Association Functional Classification. To be eligiblefor 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 Step 1/Study entry.Co-morbid illnesses or other concurrent disease that would make the patient inappropriatefor entry into this study (i.e., unable to tolerate 6 months of combination chemotherapyor interfere significantly with the proper assessment of safety and toxicity of theprescribed regimens or prevent required follow-up).Ineligibility Criteria for Cohort A Arm-2 patients on Second RandomizationPregnancy or lactation at the time of randomization.No longer a candidate for systemic chemotherapy (FOLFOX, CAPOX, and mFOLFIRINOX) in theopinion 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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
    • Trinitas Regional Medical Center – Williamson Street Campus
  • Personalized Oncology Promoting Equity for Black Lives (PROPEL) - NCT06073626

    The specific aims of this study are: 1) Test the efficacy of a culturally tailored and interactive electronic relational agent (RA) intervention vs. enhanced usual care (EUC) consisting of clinical letter and genetic recommendation on engagement in genetic education and genetic testing uptake; 2) Evaluate the impact of the RA vs. EUC on informed decision-making and psychosocial outcomes; and 3) Explore potential mechanisms by assessing mediators and moderations of efficacy.

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    • Protocol Number:
      132309

    • Principal Investigator:
      Anita Kinney PhD,RN

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Corpus Uteri,Prostate,Pancreas,Breast,Ovary,Colon

      • Contacts:

      • Rutgers University Prinicipal Investigator: Anita Kinney PhD,RN

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • 18-80 years of age
    • Identify as Black or African American
    • At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, pancreatic
    • Have received treatment or follow-up oncology care at one of the participating sites in the prior two years.
    • Meet National Comprehensive Cancer Network criteria for germline GT
    • Able to read and speak in English.

    Exclusion Criteria:

    • Do not speak English
    • Unable to access the Internet
    • Have previously undergone germline genetic testing for hereditary cancer risk
    • Are unable to provide informed consent

    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
    • Clara Maass Medical Center
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Hamilton
    • Robert Wood Johnson University Hospital
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
    • Trinitas Regional Medical Center – Williamson Street Campus
  • 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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    • Protocol Number:
      132003

    • Principal Investigator:
      Carolyn Heckman Ph.D.

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Rectum,Colon

      • Contacts:

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

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

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    • Protocol Number:
      072303

    • Principal Investigator:
      Howard Hochster M.D

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB TAS-OX

      • Contacts:

      • Rutgers University Prinicipal Investigator: Howard Hochster M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

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

    Exclusion Criteria:

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

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

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

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
    • Trinitas Regional Medical Center – Williamson Street Campus
  • Video Education with Result Dependent dIsclosure (VERDI) - NCT05225428

    The overall study objective is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers. This developmental work is imperative as the VERDI models utilized at DFCI in research studies #18-411 (ProActive), #17-409 (ProGen), #19-068 (OPT-IN), and #19-652 (GeneBOPP) have been overwhelmingly used in DFCI patients of Caucasian ancestry. While DFCI participants have responded well, in an effort improve the generalizability of VERDI and expand it to a diverse patient population, qualitative feedback is being sought explicitly from patients who self-identify as Black and Latinx patients. A brief qualitative assessment among a small, cohort of English and Spanish speaking Black and Latinx participants will first be conducted to identify refinements to video education (VE) that may increase the utility of the VERDI model for patients in these traditionally underserved populations. Participants in the qualitative assessment study will receive VE exclusively for pretest education, followed by a short interview with research staff regarding their experiences with the VE model. The qualitative assessment study will precede a large-scale randomized controlled trial of VERDI vs standard genetic counseling (SGC), as informed by the results of the developmental study. We hypothesize that the data yielded from the completion of the study objectives will assist in further refining the VERDI model and its use in clinical practices for the purpose of increasing genetic testing uptake and improving patient outcomes in minority populations that have been underrepresented in similar research to date.

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    • Protocol Number:
      042207

    • Principal Investigator:
      Deborah Toppmeyer M.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Pancreas,Melanoma, Skin,Colon,Ovary,Soft Tissue,Prostate,Kidney,Breast

      • Contacts:

      • Rutgers University Prinicipal Investigator: Deborah Toppmeyer M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age ≥ 18 years
    • Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
    • Ability to understand spoken or written English or Spanish in a healthcare context
    • Ability to understand and the willingness to sign a written informed consent document
    • Black or Latinx (qualitative assessment study only)

    Exclusion Criteria:

    • Prior cancer genetic testing
    • Prior germline genetic testing
    • Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
    • Currently pregnant
    • Currently incarcerated

    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