A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
NCT ID: NCT00642603
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
41 participants
INTERVENTIONAL
2008-05-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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XELOX + bevacizumab (Q2W)
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
XELIRI + bevacizumab (Q2W)
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
irinotecan
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
* ≥1 measurable target lesion
* Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Exclusion Criteria
* History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
* Clinically significant cardiovascular disease
* Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
* Chronic daily treatment with \>325 mg/day aspirin
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Sugar Land, 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
Countries
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Other Identifiers
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ML21567
Identifier Type: -
Identifier Source: org_study_id
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