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A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
Sponsor: Hoffmann-La Roche
Summary
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Official title: A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2008-05
Completion Date
2009-03
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle
oxaliplatin
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
irinotecan
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Locations (76)
PARK Springs, Arizona, United States
Sedona, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Colton, California, United States
Greenbrae, California, United States
Loma Linda, California, United States
Modesto, California, United States
Montebello, California, United States
Pomona, California, United States
Sacramento, California, United States
Norwich, Connecticut, United States
Waterbury, Connecticut, United States
Lake Worth, Florida, United States
Miami Shores, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Ocoee, Florida, United States
Marietta, Georgia, United States
Niles, Illinois, United States
Paducah, Kentucky, United States
Alexandria, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Westminster, Maryland, United States
Pittsfield, Massachusetts, United States
Worcester, Massachusetts, United States
Kalamazoo, Michigan, United States
Duluth, Minnesota, United States
Jefferson City, Missouri, United States
Great Falls, Montana, United States
Las Vegas, Nevada, United States
Neptune City, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Santa Fe, New Mexico, United States
Brooklyn, New York, United States
Huntington Station, New York, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Canton, Ohio, United States
Eugene, Oregon, United States
Ephrata, Pennsylvania, United States
Langhorne, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Scranton, Pennsylvania, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Florence, South Carolina, United States
Sumter, South Carolina, United States
Chattanooga, Tennessee, United States
Cookeville, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Arlington, Texas, United States
Beaumont, Texas, United States
Bedford, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Garland, Texas, United States
Lewisville, Texas, United States
Mesquite, Texas, United States
Paris, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Sugarland, Texas, United States
Waco, Texas, United States
Webster, Texas, United States
Salt Lake City, Utah, United States
Christiansburg, Virginia, United States
Seattle, Washington, United States