Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma
• •No CNS metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •Over 18
• •Performance status:
• •Karnofsky 60-100%
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •WBC at least 3,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hemoglobin at least 10.0 g/dL
• •Hepatic:
• •Bilirubin no greater than 5 times normal
• •AST/ALT no greater than 5 times normal
• •Alkaline phosphatase no greater than 5 times normal
• •Renal:
• •Creatinine clearance at least 30 mL/min
• •Gastrointestinal:
• •No grade 2 or greater nausea or grade 1 or greater vomiting
• •No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction)
• •Other:
• •No prior unanticipated severe reaction to fluoropyrimidine therapy
• •No known hypersensitivity to fluorouracil
• •No known dihydropyrimidine dehydrogenase deficiency
• •No active infection
• •No other serious concurrent systemic disorders that would preclude study participation
• •No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •No prior capecitabine
• •No prior chemotherapy for advanced pancreatic cancer
• •At least 1 year since prior radiochemotherapy for pancreatic cancer
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •See Chemotherapy
• •At least 1 year since prior adjuvant radiotherapy for pancreatic cancer
• •No concurrent radiotherapy
• •Surgery:
• •Prior Whipple procedure or duodenal bypass allowed
• •Other:
• •At least 1 month since prior investigational agents
• •No concurrent sorivudine or its chemically related analogues (e.g., brivudine)
• •No other concurrent anticancer or investigational drugs