Continuing Bevacizumab Therapy for Metastatic Colorectal Cancer
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.
Dr. Philip Gold and Dr. Anthony Shields, Southwest Oncology Group; Dr. Axel Grothey, North Central Cancer Treatment Group; Dr. Leonard Saltz, Cancer and Leukemia Group B; Dr. Steven Cohen, Eastern Cooperative Oncology Group; and Dr. Scott Berry, NCIC-Clinical Trials Group.
Why This Trial Is Important
Patients with metastatic colorectal cancer are often treated with the drug oxaliplatin and the monoclonal antibody 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 inhibits the formation of new blood vessels that tumors need for continued growth and 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 treatment will help improve survival when used in second-line therapy in 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 agents 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 benefit in continuing to treat patients with bevacizumab if they have progressed on a regimen containing it," said Dr. Gold.
"Bevacizumab may make tumors more susceptible to chemotherapy by normalizing the tumor vasculature, and emerging data suggest that bevacizumab and cetuximab may produce a synergistic effect," Dr. Gold added. "So, there is a good rationale to see if continuing bevacizumab in combination with cetuximab will help improve outcomes for patients, perhaps helping them live longer."
For More Information
See the lists of entry criteria and trial contact information at or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.