A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen
NCT00615056
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Histologically documented colorectal cancer plus one of the following:
- Failure of one prior irinotecan- or oxaliplatin-containing regimen, or
- Adjuvant refractory to irinotecan- or oxaliplatin-containing regimen.
- Prior treatment in first line metastatic setting with more than one regimen
- Prior irradiation of more than 25% of bone marrow.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Mobile, Alabama
- Tucson, Arizona
- Fresno, California
- Stamford, Connecticut
- Washington, District of Columbia
- Jacksonville, Florida
- New Port Richey, Florida
- Tamarac, Florida
- Rockford, Illinois
- Terre Haute, Indiana
- New Orleans, Louisiana
- Annapolis, Maryland
- Pittsfield, Massachusetts
- Minneapolis, Minnesota
- Columbia, Missouri
- Billings, Montana
- Las Vegas, Nevada
- Hooksett, New Hampshire
- Lebanon, New Hampshire
- Rockville Centre, New York
- Greenville, North Carolina
- Hendersonville, North Carolina
- Hickory, North Carolina
- Winston - Salem, North Carolina
- Zanesville, Ohio
- Charleston, South Carolina
- Temple, Texas
- Newport News, Virginia
- Milwaukee, Wisconsin
- Halifax, Nova Scotia
- Kingston, Ontario
- Kitchener, Ontario
- Windsor, Ontario
- Fleurimont, Quebec
- Kashiwa, Chiba
- Suntougun, Shizuoka
- Chuo-ku, Tokyo
- Poway, California
- Washington, District of Columbia
- Tampa, Florida
- New York, New York
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen | |||
Official Title ICMJE | A Randomized, Phase 2 Study Of FOLFOX Or FOLFIRI With AG-013736 Or Bevacizumab (Avastin) In Patients With Metastatic Colorectal Cancer After Failure Of An Irinotecan Or Oxaliplatin-Containing First-Line Regimen | |||
Brief Summary | The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Colorectal Neoplasms | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 171 | |||
Original Estimated Enrollment ICMJE | 176 | |||
Actual Study Completion Date ICMJE | April 2012 | |||
Actual Primary Completion Date | March 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, France, Italy, Japan, Korea, Republic of, Poland, Spain, United States | |||
Removed Location Countries | Belgium, Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00615056 | |||
Other Study ID Numbers ICMJE | A4061034 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |