Name of the Trial
Phase III Randomized Study of Irinotecan Hydrochloride-Based Chemotherapy and Cetuximab with versus without Bevacizumab in Patients with Metastatic Colorectal Cancer that Progressed on First-Line Therapy (SWOG-S0600). See the protocol summary at http://cancer.gov/clinicaltrials/SWOG-S0600.

Principal Investigators
Dr. Philip Gold and Dr. Anthony Shields, SWOG; Dr. Axel Grothey, North Central Cancer Treatment Group; Dr. Leonard Saltz, CALGB; Dr. Steven Cohen, ECOG; and Dr. Scott Berry, NCIC-Clinical Trials Group

Why This Trial Is Important
Patients with metastatic colorectal cancer are often treated with the drugs oxaliplatin and bevacizumab in combination with other drugs. If the cancer progresses while the patient is being treated with these agents, second-line therapy with different drugs may be initiated.

Bevacizumab, a monoclonal antibody that inhibits the formation of new blood vessels tumors need for continued growth, has been shown to help extend the survival of patients with advanced or metastatic colorectal cancer when used as part of initial, or first-line, therapy. It is unknown, however, whether continuing bevacizumab will help improve survival when used in second-line therapy to treat patients whose cancer has progressed despite first-line treatment with bevacizumab and chemotherapy.

In this trial, patients with metastatic colorectal cancer that has progressed on first-line therapy containing oxaliplatin and bevacizumab will be treated with the drugs irinotecan and cetuximab. The patients will also be randomly assigned to receive either a low dose of bevacizumab, a high dose of bevacizumab, or no additional bevacizumab.

"The goal of this trial is to determine whether there is a benefit to continuing to treat patients with bevacizumab if they have progressed on a regimen containing it," said Dr. Gold.

For More Information
See the lists of entry criteria and trial contact information at http://cancer.gov/clinicaltrials/SWOG-S0600 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.