Name of the Trial
Phase III Randomized Study of Cetuximab and/or Bevacizumab in Combination with Either Oxaliplatin, Fluorouracil, and Leucovorin Calcium (FOLFOX) or Irinotecan Hydrochloride, Fluorouracil, and Leucovorin Calcium (FOLFIRI) in Patients with Previously Untreated Metastatic Adenocarcinoma of the Colon or Rectum (CALGB-C80405). See the protocol summary at http://cancer.gov/clinicaltrials/CALGB-C80405.

Principal Investigators
Dr. Alan Venook, Cancer and Leukemia Group B; and Dr. Charles Blanke, Southwest Oncology Group

Why This Trial Is Important
Colon and rectal cancer (colorectal cancer) are highly treatable if caught at an early stage. Yet, colorectal cancer is expected to cause more than 55,000 deaths in the United States in 2006, many because the cancer will not be detected until it has spread (metastasized) beyond the colon or rectum. Patients with metastatic colorectal cancer face a poor likelihood of survival. Consequently, the need for more effective treatments is great.

In this trial, patients will receive one of two targeted agents, or a combination of the two, that were recently approved by the U.S. Food and Drug Administration for use with combination chemotherapy in the treatment of metastatic colorectal cancer.

The two targeted agents, bevacizumab (Avastin) and cetuximab (Erbitux), are monoclonal antibodies that seek out and block the activity of different proteins important for tumor cell growth and spread. These proteins, vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR), respectively, are often found in much greater abundance on cancer cells than on normal cells.

"We want to see if combining these agents along with standard chemotherapy can help these patients live longer and possibly shrink their tumors enough to allow potentially curative surgical treatment," said Dr. Venook.

Who Can Join This Trial

Researchers will enroll 2,300 patients with metastatic colorectal cancer who have not received prior treatment. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/CALGB-C80405. This clinical trial is eligible for special Medicare coverage.

Study Sites and Contact Information
Study sites in the United States and elsewhere are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/CALGB-C80405 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.