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Trial record 1 of 1 for:    Short-course Oxaliplatin as First-Line Treatment for Patients with Metastatic Colorectal Cancer
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A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00642603
Recruitment Status : Terminated
First Posted : March 25, 2008
Results First Posted : June 23, 2011
Last Update Posted : March 29, 2018
Information provided by:
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine [Xeloda] Drug: bevacizumab [Avastin] Drug: oxaliplatin Drug: irinotecan Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: XELOX + bevacizumab (Q2W) Drug: capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

Drug: bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle

Drug: oxaliplatin
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Experimental: XELIRI + bevacizumab (Q2W) Drug: capecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

Drug: bevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle

Drug: irinotecan
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Primary Outcome Measures :
  1. Progression-free Survival (PFS) in U.S. Patients Only [ Time Frame: From first patient enrolled up to approximately 48 months ]
    PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, ≥18 years of age
  • 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:

  • Prior systemic therapy for advanced or metastatic disease
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00642603

Hide Hide 76 study locations
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United States, Arizona
PARK Springs, Arizona, United States, 71913
Sedona, Arizona, United States, 86336
Tucson, Arizona, United States, 85712
United States, California
Anaheim, California, United States, 92801
Colton, California, United States, 92324
Greenbrae, California, United States, 94904
Loma Linda, California, United States, 92354
Modesto, California, United States, 95355
Montebello, California, United States, 90640
Pomona, California, United States, 91767
Sacramento, California, United States, 95816
United States, Connecticut
Norwich, Connecticut, United States, 06360
Waterbury, Connecticut, United States, 06708
United States, Florida
Lake Worth, Florida, United States, 33431
Miami Shores, Florida, United States, 33179
New Port Richey, Florida, United States, 34655
Ocala, Florida, United States, 34474
Ocoee, Florida, United States, 34761
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Illinois
Niles, Illinois, United States, 60714
United States, Kentucky
Paducah, Kentucky, United States, 42002
United States, Louisiana
Alexandria, Louisiana, United States, 71301
United States, Maryland
Baltimore, Maryland, United States, 21204
Baltimore, Maryland, United States, 21237
Westminster, Maryland, United States, 21157
United States, Massachusetts
Pittsfield, Massachusetts, United States, 01201
Worcester, Massachusetts, United States, 01608
United States, Michigan
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
Duluth, Minnesota, United States, 55805
United States, Missouri
Jefferson City, Missouri, United States, 65109
United States, Montana
Great Falls, Montana, United States, 59405
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Neptune, New Jersey, United States, 07754
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Albuquerque, New Mexico, United States, 87131-5636
Santa Fe, New Mexico, United States, 87505
United States, New York
Brooklyn, New York, United States, 11219
Huntington Station, New York, United States, 11746
United States, North Carolina
Durham, North Carolina, United States, 27710
Hickory, North Carolina, United States, 28602
United States, Ohio
Canton, Ohio, United States, 44718
United States, Oregon
Eugene, Oregon, United States, 97401-8122
United States, Pennsylvania
Ephrata, Pennsylvania, United States, 17522
Langhorne, Pennsylvania, United States, 19047
Philadelphia, Pennsylvania, United States, 19102
Scranton, Pennsylvania, United States, 18510
United States, South Carolina
Charleston, South Carolina, United States, 29403-5740
Charleston, South Carolina, United States, 29406
Florence, South Carolina, United States, 29506
Sumter, South Carolina, United States, 29150
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Cookeville, Tennessee, United States, 38501
Nashville, Tennessee, United States, 37203
United States, Texas
Amarillo, Texas, United States, 79106
Arlington, Texas, United States, 76014
Beaumont, Texas, United States, 77702-1449
Bedford, Texas, United States, 76022
Carrollton, Texas, United States, 75010
Corpus Christi, Texas, United States, 78412
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75237
Fort Worth, Texas, United States, 76104
Garland, Texas, United States, 75042
Lewisville, Texas, United States, 75067
Mesquite, Texas, United States, 75150
Paris, Texas, United States, 75460
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78229
Southlake, Texas, United States, 76092
Sugar Land, Texas, United States, 77479
Waco, Texas, United States, 76712
Webster, Texas, United States, 77598-4420
United States, Utah
Salt Lake City, Utah, United States, 84106
United States, Virginia
Christiansburg, Virginia, United States, 24073
United States, Washington
Seattle, Washington, United States, 98133
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
Additional Information:
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Responsible Party: Disclosures Group, Hoffmann-La Roche Identifier: NCT00642603    
Other Study ID Numbers: ML21567
First Posted: March 25, 2008    Key Record Dates
Results First Posted: June 23, 2011
Last Update Posted: March 29, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors