RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combining fluorouracil and leucovorin with or without oxaliplatin in treating patients who have recurrent metastatic colorectal cancer.
OBJECTIVES: I. Compare the overall response rate and overall survival of patients with recurrent metastatic colorectal adenocarcinoma treated with third-line therapy comprising fluorouracil and leucovorin calcium with or without oxaliplatin. II. Compare the onset and duration of complete and partial responses and duration of disease stabilization in patients treated with these regimens. III. Compare the proportion of patients with stable disease and proportion of patients with tumor-related symptomatic improvement treated with these regimens. IV. Compare the time to disease progression and time to tumor-related symptomatic worsening in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 2-4 minutes followed by fluorouracil IV continuously over 22 hours on day 1. On day 2, patients receive leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 2 weeks for at least 1 year in the absence of disease progression. Patients are followed at day 30 and then for approximately 6 months. PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
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Arizona Clinical Research Center
Tucson, Arizona, United States
Arkansas Cancer Clinic, P.A.
Pine Bluff, Arkansas, United States
Citrus Valley Medical Center
Covina, California, United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
California Cancer Care, Inc.
Greenbrae, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Kenmar Research Institute
Los Angeles, California, United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States
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