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

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas
• •* Locally advanced or metastatic disease not amenable to curative surgical resection
• •* Macroscopic residual disease after prior resection with histological confirmation is allowed
• •Unidimensionally measurable disease
• •No intracerebral metastases or meningeal carcinomatosis
• •PATIENT CHARACTERISTICS:
• •Age:
• •Over 18
• •Performance status:
• •WHO 0-2
• •Life expectancy:
• •More than 3 months
• •Hematopoietic:
• •WBC greater than 3,000/mm3
• •Neutrophil count greater than 1,500/mm3
• •Platelet count greater than 100,000/mm3
• •Hepatic:
• •Bilirubin less than 2 mg/dL
• •Renal:
• •Creatinine less than 2 mg/dL
• •Creatinine clearance greater than 50 mL/min
• •Cardiovascular:
• •No New York Heart Association class III or IV heart disease
• •No uncontrolled angina pectoris
• •Other:
• •No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No other concurrent uncontrolled medical condition
• •No other medical or psychiatric condition that would preclude study
• •No known hypersensitivity to fluorouracil
• •No dihydropyrimidine dehydrogenase deficiency
• •No known malabsorption syndromes
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •No prior chemotherapy (including preoperative or adjuvant) for this disease
• •No other concurrent cytotoxic chemotherapy
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •No prior radiotherapy (including preoperative or adjuvant) for this disease
• •Surgery:
• •See Disease Characteristics
• •Other:
• •No prior investigational drugs (including preoperative or adjuvant) for this disease
• •No other concurrent investigational drugs
• •No concurrent dipyridamole or allopurinol
• •No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)