A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Inclusion criteria

• Patients must have biopsy-proven, resected with curative intent cholangiocarcinoma, gallbladder, pancreatic or ampullary adenocarcinoma.
• Patients must be 18 years or older.
• Patients must have a NCI CTC Performance Status of 0-2.
• Patients must not have any prior chemotherapy or radiation therapy for this current malignancy.
• At least 3 weeks should have elapsed since any surgery requiring general anesthesia.
• Patients must have no prior malignancies except for basal or squamous skin cancers, cervical carcinoma-in-situ, unless in remission for >5years
• Pregnant patients are not eligible. Non-pregnant status will be determined in all women of childbearing potential. All patients will be required to use an effective means of contraception if sexually active during therapy.
• Initial Required Laboratory Values:
• Absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 150, 000/mm3, and hemoglobin ≥ 9 g/dL.
• Serum creatinine should be ≤ 2 mg/dL.
• Serum bilirubin should be ≤ 3.0 mg/dL (biliary stents allowed).
• Serum transaminases should be ≤ 5-fold the institutional upper limits.
• Patients must not have any co-existing severe medical illnesses, such as unstable angina, uncontrolled diabetes mellitus, uncontrolled arrhythmia or uncontrolled infection.
• Patients must be able to sign an informed consent.

Exclusion criteria

• None