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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
May 1, 2008
Primary Completion Date
March 1, 2009
Completion Date
March 1, 2009
Last Updated
March 29, 2018
41
ACTUAL participants
capecitabine [Xeloda]
DRUG
capecitabine [Xeloda]
DRUG
bevacizumab [Avastin]
DRUG
oxaliplatin
DRUG
irinotecan
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT04704661
NCT06696768
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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