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
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival (PFS) in U.S. Patients Only
Outcome Description:
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.
Outcome Time Frame:
From first patient enrolled up to approximately 48 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
ML21567
NCT ID:
NCT00642603
Start Date:
May 2008
Completion Date:
September 2012
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Alexandria, Minnesota 56308 | |
| Albany, Georgia 31701 | |
| Great Falls, Montana 59405 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| Louisville, Kentucky 40207 | |
| McLean, Virginia 22101 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Metairie, Louisiana 70006 | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Charleston, South Carolina | |
| Las Vegas, Nevada 89109 | |
| Salt Lake City, Utah 84112 |
