bruog 295: adjuvant folfox-a for resected pancreatic cancer: a phase ii brown university oncology research group trial

Conditions: Pancreatic Cancer

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.

see summary above

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.

Keywords: pancreatic cancer adjuvant pancreas resected invasive adenocarcinoma adenosquamous cancer intraductal papillary mucinous neoplasm