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

The objective of this study are to determine the relapse-free survival of resected pancreatic
cancer patients following two novel regimens. The secondary objectives are 1) to assess the
toxicity of each of these regimens in this setting. 2) To perform exploratory genomic
analyses as a means of assessing molecular characteristics potentially associated with risk
of relapse with one or both of the regimens. 3) To determine the relationship between known
mutations and metabolic activity as measured by FDG-PET and risk of relapse.

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 ECOG performance status of 0-2.

- Patients must have normal organ and marrow function measured within 2 weeks. prior to
registration as follows:

ANC > 1,500/µL Platelets > 100,000/µL Total bilirubim less than 2-fold ULN
AST(SGOT)/ALT(SGPT)<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 stronglt advised to use
appropriate contraceptive measures.

Women must not be pregnant or breast-feeding. All agents used in this study as well as
radiation therapy to the abdomen have the potential for teratogenic or abortifacient
effects. All females of childbearing potential must have a blood test or urine study within
2 weeks prior to registration to rule out pregnancy.

- Patients must not be receiving any other investigational agents.

- Patients with known metastases are not eligible.

- Patients with wounds that have not fully healed are not eligible.

Exclusion Criteria: