• Survival at 1 year [ Designated as safety issue: No ]
  

• Quality of life [ Designated as safety issue: No ]
  
• Median survival rate [ Designated as safety issue: No ]
  
• Survival rate at 2 years [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  
• Objective response rate [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine.
• Compare the median and 2-year survival rates and the objective response rates of patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter.

Patients are followed every 3 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.

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)