A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

You may be eligible if

• DISEASE CHARACTERISTICS:
• 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.
• PRIOR/CONCURRENT THERAPY:
• Biologic Therapy: More than 4 weeks since immunotherapy.
• Chemotherapy:
• 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.
• Radiotherapy:
• 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.
• Surgery:
• Prior resection allowed.
• Biliary decompression or gastric bypass allowed.
• PATIENT CHARACTERISTICS:
• Age: 18 and over.
• Performance status: ECOG 0-2.
• Hematopoietic:
• ANC greater than 2,000/mm(3).
• Platelets greater than 100,000/mm(3).
• Hepatic: AST/ALT no greater than 2.5 times normal.
• Renal:
• Creatinine less than 1.5 mg/dL.
• Creatinine clearance at least 60 mL/min,
• Cardiovascular:
• No myocardial infarction within 6 months.
• No unstable angina.
• No congestive heart failure (NYHA class III/IV).
• OTHER:
• HIV seronegative.
• 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.