BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: FOLFOXA
Intervention description: Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Cancer; Adjuvant; Pancreas; Resected; Invasive adenocarcinoma; adenosquamous cancer; Intraductal papillary mucinous neoplasm

Summary:

      The investigators preliminary data suggests that FOLFOX-A may have equal or superior activity
      as compared to FOLFIRINOX and appears to be better tolerated. Therefore, FOLFOX-A may be a
      better regimen in the adjuvant setting for patients with resected pancreatic cancer. This
      protocol will obtain preliminary data on safety and disease-free and overall survival
      following administration of FOLFOX-A for patients with resected pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic proof of primary pancreas invasive adenocarcinoma or adenosquamous cancer,
             managed with a potentially curative resection (i.e., removal of all gross tumor).
             Patients with invasive adenocarcinoma that also contains a component of intraductal
             papillary mucinous neoplasm (IPMN) are eligible.

          -  Interval between definitive tumor-related surgery and registration between 21-70 days.

          -  Patients will be staged according to the 6th edition AJCC staging system with
             pathologic stage T1-3, N0-1, M-0 being eligible.

          -  Post resection serum CA19-9 ≤ 180 units/mL within 21 days of registration on study.

          -  Preexisting neuropathy < grade 1 (per CTCAE).

          -  ECOG performance status 0 or 1.

          -  Age ≥ 18

          -  Not pregnant and not nursing. Women of child bearing potential must have a negative
             serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG)
             within 7 days prior to beginning of treatment. Post-menopausal women (surgical
             menopause of lack of menses >12 months) do not need to have a pregnancy test, please
             document status.

          -  Women of childbearing potential and sexually active males must use an effective
             contraception method during treatment and for three months after completing treatment.

          -  Required Initial Laboratory Values:

               -  Neutrophils ≥ 1,500/mm3

               -  Platelet count ≥ 100,000/mm3

               -  Creatinine ≤ 1.5 mg/dL -or- creatinine clearance ≥ 60 mL/min

               -  Total bilirubin ≤ 1.5 x ULN

               -  AST (SGOT) & ALT (SGPT) ≤ 2.5 x ULN

               -  Alkaline phosphatases < 2.5x ULN

          -  Abdominal CT scan with contrast and chest CT/x-ray (CT of chest preferred) within 6
             weeks of registration on study. Patients can have PET/MRI of the chest/abdomen
             instead.

        Exclusion Criteria:

          -  Patients with serious medical risk factors involving any of the major organ systems
             such that the investigator considers it unsafe for the patient to receive FOLFOX-A

          -  Prior hypersensitivity to Oxaliplatin or Abraxane that in the investigators opinion
             would put the patient at risk if re-exposed

          -  Patients with islet cell (neuroendocrine) tumors, cystadenomas, cystadenocarcinomas,
             carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas.

          -  Prior systemic chemotherapy for pancreas cancer; note that prior chemotherapy for a
             different cancer is allowable. Patients must not have received chemotherapy for a year
             prior to registering on study

          -  No prior invasive malignancy within the prior two years. However, patients with an
             early stage malignancy that is not expected to require treatment in the next 2 years
             (such as early stage, resected breast cancer or asymptomatic prostate cancer) are
             eligible. This must be documented.