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

Date de début de l'étude : 1 avril 2013

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.