Histologically or cytologically proven unresectable adenocarcinoma of the pancreas or ampulla of Vater. Surgical consult at NCI confirming unresectability fulfills requirement.
Unresectable disease defined as tumor with: Gross involvement of regional nodes or direct extension to any of the following sites: Duodenum, Spleen, Bile duct , Colon, Peripancreatic tissue, Adjacent large vessels, Stomach.
Metastatic disease requiring local radiotherapy allowed. No CNS metastasis.
No lymphomas or neuroendocrine tumors.
No peritoneal carcinomatosis.
Biologic Therapy: More than 4 weeks since immunotherapy.
No prior chemotherapy for newly diagnosed disease.
More than 4 weeks since chemotherapy for recurrent disease (6 weeks since nitrosoureas, mitomycin, or suramin).
Endocrine Therapy: More than 4 weeks since hormonal therapy.
No prior radiotherapy for newly diagnosed disease.
No prior abdominal or pelvic radiotherapy.
More than 4 weeks since radiotherapy for recurrent disease. No prior radiotherapy for locally advanced disease after resection allowed.
Prior resection allowed.
Biliary decompression or gastric bypass allowed.
Age: 18 and over.
Performance status: ECOG 0-2.
ANC greater than 2,000/mm(3).
Platelets greater than 100,000/mm(3).
Hepatic: AST/ALT no greater than 2.5 times normal.
Creatinine less than 1.5 mg/dL.
Creatinine clearance at least 60 mL/min,
No myocardial infarction within 6 months.
No unstable angina.
No congestive heart failure (NYHA class III/IV).
No medical or psychiatric contraindication to protocol therapy.
No concurrent malignancy other than: Skin cancer, Cervical carcinoma in situ.
No pregnant or nursing women.
Adequate contraception required of fertile patients.