A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma

Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
• Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible).
• Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
• Age > 18 years.
• Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows:

Absolute Neutrophil Count (ANC) > 1,500/µL Platelets > 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)<2.5X institutional upper limit of normal Creatinine clearance > 60mL/min for patients with creatinine levels above institutional normal.

• Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.
• Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures.
• Women must not be pregnant or breast-feeding.

Exclusion Criteria:

• Patients receiving any other investigational agents.
• Patients with known metastases.
• Patients with wounds that have not fully healed.