Oxaliplatin and Bevacizumab (Avastin™) With Either Fluorouracil and Leucovorin or Capecitabine in Treating Patients With Advanced Colorectal Cancer
NCT00062426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2013-11-06
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.
Conditions
Interventions
- BIOLOGICAL
- DRUG
- DRUG
- DRUG
-
leucovorin calcium
- DRUG
Sponsors & Collaborators
-
Prologue Research International
lead INDUSTRY
Principal Investigators
-
Richard A. Gams, MD · Prologue Research International
-
Lauri Welles, MD · Sanofi-Synthelabo
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-05-31
- Completion
- 2011-02-28
Countries
- United States
Study Locations
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