Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00062426
- Lead Sponsor
- Prologue Research International
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, leucovorin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different combinations may kill more tumor cells. Monoclonal antibodies, such as bevacizumab (Avastin™), can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. It is not yet known which regimen works better in treating advanced colorectal cancer.
PURPOSE: This randomized phase III trial is to see if oxaliplatin and bevacizumab work better when combined with either fluorouracil and leucovorin or capecitabine in treating patients who have metastatic or recurrent colorectal cancer.
- Detailed Description
OBJECTIVES:
* Compare the incidence of grade 3 and 4 toxic effects occurring within the first 12 weeks of treatment with 2 different schedules of oxaliplatin, bevacizumab (Avastin™), leucovorin calcium, and fluorouracil or with oxaliplatin, Avastin™, and capecitabine in patients with advanced colorectal cancer.
* Compare the overall response rate, progression-free survival, and time to treatment failure in patients treated with these regimens.
* Compare the composite toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive bevacizumab (Avastin™) IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil (5-FU) IV over 46 hours beginning on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on days 1 and 15 and leucovorin calcium IV over 10 minutes and 5-FU IV over 3 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive Avastin™ IV over 30-90 minutes and oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month, every 3 months for at least 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 375 patients (125 per treatment arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- 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
Related Research Topics
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Trial Locations
- Locations (52)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
California Cancer Care, Inc.
🇺🇸Greenbrae, California, United States
Valley Tumor Medical Group
🇺🇸Lancaster, California, United States
Cancer and Blood Institute of the Desert
🇺🇸Rancho Mirage, California, United States
Rocky Mountain Cancer Centers - Midtown
🇺🇸Denver, Colorado, United States
Northwestern Connecticut Oncology-Hematology Associates
🇺🇸Torrington, Connecticut, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Lynn Regional Cancer Center West
🇺🇸Boca Raton, Florida, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Scroll for more (42 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States