Cancer Clinical Trial
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
This is a Phase II study of the drug combination of Oxaliplatin, Avastin and capecitabine. This is an open-label study.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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