The National Cancer Institute (NCI) today announced that it is planning to open a clinical trial that will evaluate bevacizumab (Avastin™), an antiangiogenic agent, for patients with metastatic colorectal cancer who are no longer benefiting from effective, standard treatment regimens. Patients in this trial will receive bevacizumab in combination with 5-fluorouracil (5FU) and leucovorin.

This treatment referral center trial is being developed by NCI's Cancer Therapy Evaluation Program (CTEP) in collaboration with Genentech, the manufacturer of bevacizumab. "The trial will be open at multiple locations across the United States and is anticipated to begin enrolling patients within the next three to four months," said Helen Chen, M.D., of CTEP, who is overseeing the study for NCI.

This new trial will be open to patients who have previously received both oxaliplatin and irinotecan regimens and are no longer responding to, or can no longer tolerate, these established agents. Since other studies have suggested that bevacizumab as a single agent is not useful in progressive colorectal cancer, the new trial will combine bevacizumab with 5FU and leucovorin in a manner similar to that reported by Fairooz Kabbinavar, University of California Los Angeles, and colleagues in the Jan. 1, 2003, Journal of Clinical Oncology. An NCI-sponsored Phase III trial evaluating bevacizumab with oxaliplatin for colon cancer patients previously treated with irinotecan has recently completed patient accrual and results are pending.

The study being planned is part of NCI's continuing collaboration with Genentech under a cooperative research and development agreement. The company is providing bevacizumab for three ongoing Phase III trials and a large Phase II program that encompasses more than 22 trials in a variety of malignancies. The collaboration has yielded encouraging results for bevacizumab, including a positive, randomized Phase II trial of bevacizumab in renal cell carcinoma, which is now being definitively tested in an NCI-cooperative group Phase III trial. Bevacizumab, although generally well-tolerated by patients in these trials, can cause high blood pressure that requires treatment and may be associated with rare, life-threatening complications such as perforation of the bowel walls.

NCI has several other early clinical trials for patients with metastatic colorectal cancer that does not respond to treatment. NCI and Genentech also are working together to develop trials for combining bevacizumab with other targeted drugs for patients with colon cancer refractory to chemotherapy.

For more information about this trial and other treatment trials that are currently enrolling metastatic colorectal cancer patients, contact the NCI's Cancer Information Service toll-free, Monday through Friday, 9 a.m. to 4:30 p.m., at 1-800-4-CANCER (1-800-422-6237) for information in English or Spanish. The number for callers with TTY equipment is 1-800-332-8615.

For more information about cancer, visit NCI's Web site at http://www.cancer.gov.

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