A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer

Brief Summary

Detailed Description

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.

Primary Outcomes

Secondary Outcomes

• Survival rate at 2 years
• Quality of life
• Median survival rate
• Toxicity
• Objective response rate