Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00008281
- Lead Sponsor
- Sanofi
- 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 which regimen of chemotherapy is more effective for metastatic colorectal cancer.
PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.
- Detailed Description
OBJECTIVES: I. Compare the overall survival of patients with metastatic colorectal carcinoma treated with fluorouracil and leucovorin calcium with vs without oxaliplatin vs oxaliplatin alone. II. Compare the response rate, time to tumor-related symptomatic worsening, time to disease progression, onset and duration of complete and partial responses, and duration of disease stabilization in patients treated with these regimens. III. Determine the safety profile of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to Karnofsky performance status (50-60% vs 70-100%), number of metastatic organs (1 vs 2 or more), and LDH value (up to 1.5 times upper limit of normal (ULN) vs greater than 1.5 times ULN). Patients are randomized to one of three treatment arms. Arm I: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on days 1 and 2. Arm II: Patients receive oxaliplatin IV over 2 hours on day 1. Arm III: Patients receive oxaliplatin IV concurrently with leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 22 hours on day 1. Leucovorin calcium and fluorouracil are administered alone on day 2 on the same schedule as on day 1. Treatment repeats every 2 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed for 30 days, every 2 weeks for up to 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 786 patients (262 per arm) will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (132)
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Oncology Center at Providence Park
🇺🇸Mobile, Alabama, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Arkansas Oncology Associates, P.A.
🇺🇸Little Rock, Arkansas, United States
Offices of Richard Shapiro, Benjamin Stafford, and Sharon J. Yee
🇺🇸Arcadia, California, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Medical Oncology Internal Medicine
🇺🇸Los Angeles, California, United States
Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Medical Oncology Care Associates
🇺🇸Orange, California, United States
P.M.K. Medical Group, Inc.
🇺🇸Oxnard, California, United States
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