Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer
Research has shown that the more drug treatments patients with cancer of the colon or rectum
receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all
patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to
tumors and increases how long patients with colorectal cancer live. However, it can
increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of
treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called
EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with
bevacizumab. One goal of this study is to find out the response rate (chance of tumor
shrinking) with two treatments for colorectal cancer. All patients will get capecitabine,
oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are
approved to treat colorectal cancer. This research study is being done to find the best,
safest way to combine these therapies.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the objective response rate using RESIST criteria after every second cycle
every 6-9 weeks
No
Steven Cohen, MD
Principal Investigator
Fox Chase Cancer Center
United States: Institutional Review Board
FRN-GI-002
NCT00321100
April 2006
December 2012
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |