Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• * Unresectable locally advanced or metastatic disease
• * Stage II, III, or IV
• Measurable or evaluable disease
• No elevated tumor marker (CA 19-9) only
• No clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion)
• No carcinoid, islet cell, or lymphoma of the pancreas
• No prior or concurrent brain or leptomeningeal metastases
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Performance status:
• Karnofsky 70-100%
• Life expectancy:
• At least 3 months
• Hematopoietic:
• WBC at least 3,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 9.5 g/dL
• Hepatic:
• Bilirubin no greater than 2.0 mg/dL
• ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
• No uncontrolled hepatic dysfunction
• Renal:
• Creatinine less than 2.0 mg/dL
• No uncontrolled renal dysfunction
• Cardiovascular:
• No uncontrolled cardiovascular disease requiring therapy, including the following:
• * Angina
• * Arrhythmias
• * Uncompensated cardiac failure
• * Myocardial infarction within the past 6 months
• Pulmonary:
• No uncontrolled pulmonary dysfunction
• Gastrointestinal:
• Able to take and/or retain oral medication
• No uncontrolled malabsorption syndrome or any other condition that would interfere with intestinal absorption
• Other:
• No known allergy to fluorouracil (5-FU), gemcitabine, triacetyluridine, or any of their components
• No dihydropyrimidine-dehydrogenase deficiency
• No active uncontrolled infection
• No uncontrolled neurologic or psychiatric dysfunction
• No other malignancy except previously resected basal cell cancer or curatively resected stage I or less cervical cancer that has been disease free for at least 5 years
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No concurrent biologic therapy (including immunotherapy) for cancer
• Chemotherapy:
• No prior chemotherapy for cancer other than as a radiosensitizer
• No prior 5-FU or gemcitabine other than as a radiosensitizer
• No prior triacetyluridine
• No other concurrent chemotherapy (including leucovorin calcium) for cancer
• Endocrine therapy:
• No concurrent hormonal therapy for cancer
• Concurrent megestrol, oral contraceptives, or postmenopausal estrogen replacement therapy allowed
• Radiotherapy:
• Prior radiotherapy allowed
• No concurrent radiotherapy
• Surgery:
• See Disease Characteristics
• Prior resection of pancreas allowed
• Other:
• At least 30 days since prior investigational drug or therapeutic device
• No other concurrent anticancer therapy
• No other concurrent investigational drugs or devices
• No concurrent drugs that would interact adversely with 5-FU or gemcitabine