A Phase II Study of Cetuximab Plus Biweekly Capecitabine and Oxaliplatin (C-CO2) in the Treatment of Patients With EGFR-Expressing Metastatic Colorectal Cancer
The current treatment options for metastatic colon cancer are in need of further
improvement. The three-drug combination of oxaliplatin with 5-FU/LV in the second-line
treatment of metastatic colorectal cancer have shown a significant increase in response rate
compared to 5-FU/LV alone. Oxaliplatin has recently been FDA-approved for this indication
and is now a standard first-line agent in combination with a fluoropyrimidine. Cetuximab, a
chimeric monoclonal antibody against the growth factor receptor, has shown activity with and
without irinotecan in subjects with colorectal cancer refractory to irinotecan alone.
Cetuximab has also been shown to be safe and effective when administered with infusional
5-FU/folinic acid plus irinotecan. These results suggest that the addition of cetuximab to
fluoropyrimidine/oxaliplatin-based regimen in the 1st line setting should be explored. The
use of the oral fluoropyrimidine, capecitabine, to replace infusional 5FU has been widely
used for improved convenience and possible safety. We have chosen a modified biweekly CapeOx
regimen due to its improved tolerance and response rate with a fixed dose of capecitabine
given its widespread practice and ease of use.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate for the combination treatment
6 months since the start of treatment
No
Deirdre Cohen, MD
Principal Investigator
New York University School of Medicine
United States: Institutional Review Board
NYU# 04-10 H11817
NCT00444678
June 2004
August 2013
Name | Location |
---|---|
New York University Langone Medical Center | New York, New York 10016 |
Bellevue Hospital | New York, New York 10016 |