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

Inclusion Criteria

• •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