BrUOG 295: Adjuvant FOLFOX-A For Resected Pancreatic Cancer: A Phase II Brown University Oncology Research Group Trial

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.