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Sponsors and Collaborators: |
University of Pittsburgh Genentech |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177307 |
This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine. This is an open-label study.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of the A-ICOX Regimen Consisting of Bevacizumab (Avastinâ), Intermittent Dose Capecitabine (Xelodaâ) and Oxaliplatin (Eloxatinâ) in Patients With Untreated Advanced Colorectal Cancer |
Enrollment: | 45 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ongoing clinical trials are now evaluating the addition of bevacizumab to standard chemotherapeutic regimens for colorectal cancer such as FOLFOX or FOLFIRI. In these studies the addition of bevacizumab has been safe and has not resulted in significantly increased toxicity. Our proposed regimen has the advantage of being easily administered in the outpatient setting, with potential for enhanced activity and needs to be evaluated in a clinical trial.
The patterns of care for CRC have shifted, IFL previously the standard of care, is now proven to be an inferior regimen compared to FOLFOX4. (8) The recent FDA approval in February 2004 of bevacizumab for first line therapy, which states that bevacizumab is an approved agent in combination with a 5-FU regimen, gives no clear guidelines as to the "best regimen". This is an issue that needs to be evaluated rapidly in clinical trials, and it is clear that a combination of 5-FU or capecitabine with oxaliplatin and bevacizumab is one of the most active and well-tolerated regimens. The optimum sequence, schedule and doses needs to determined in clinical trials.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
ECOG performance status of 0, 1, or 2 Estimated life expectancy of at least 12 weeks.
Exclusion Criteria:
United States, Pennsylvania | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15232 |
Principal Investigator: | Kenneth Foon, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh Cancer Institute ( nathan Bahary ) |
Study ID Numbers: | 04-118 |
Study First Received: | September 12, 2005 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00177307 |
Health Authority: | United States: Food and Drug Administration |
colon rectum |
Oxaliplatin Capecitabine Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases |
Gastrointestinal Neoplasms Bevacizumab Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |