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

A Feasibility Phase II Study of Gemcitabine With Docetaxel With Concurrent 3-D Conformal Radiation Plus Continuous Infusion 5-Fluorouracil in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

To assess the feasibility of administering induction chemotherapy with gemcitabine and docetaxel followed by concurrent radiation and continuous infusion 5FU and consolidation gemcitabine/docetaxel chemotherapy.

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