Spots Global Cancer Trial Database for Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

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Trial Identification

Brief Title: Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

Official Title: Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial

Study ID: NCT00030732

Conditions

Pancreatic Cancer

Interventions

Gemcitabine + Capecitabine

Gemcitabine alone

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.

Detailed Description: OBJECTIVES: * Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine. * Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in 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 a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. * Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration. Patients are followed every 9 weeks. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.