Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed epithelial cancer of the exocrine pancreas
• * Locally advanced (unresectable) or metastatic disease
• No islet cell tumor, lymphoma, or sarcoma of the pancreas
• No known brain metastases
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• Karnofsky 60-100%
• Life expectancy:
• Not specified
• Hematopoietic:
• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• Hepatic:
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST no greater than 5 times ULN
• Albumin at least 2.8 g/dL
• Renal:
• Creatinine no greater than 1.5 times ULN
• Cardiovascular:
• No active congestive heart failure
• No uncontrolled angina
• No myocardial infarction
• Other:
• No serious infection or life-threatening illness unrelated to tumor
• No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No overt psychosis or incompetency that would preclude study
• No history of a positive serology for HIV
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use contraception
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No prior systemic anticancer immunotherapy for pancreatic cancer
• No concurrent anticancer immunotherapy or other biologic therapy
• Chemotherapy:
• No prior systemic anticancer chemotherapy for pancreatic cancer
• Prior fluorouracil as a radiosensitizer allowed
• No prior gemcitabine as a radiosensitizer
• No other concurrent anticancer chemotherapy
• Endocrine therapy:
• Concurrent megestrol for appetite stimulation allowed
• Radiotherapy:
• At least 28 days since prior radiotherapy and recovered
• No prior radiotherapy to more than 25% of estimated bone marrow reserve
• No concurrent anticancer radiotherapy
• Surgery:
• At least 28 days since prior major surgery and recovered
• No concurrent surgery for cancer
• Other:
• No prior investigational or other systemic anticancer therapy for pancreatic cancer
• No other concurrent investigational drugs