Name of the Trial
Phase III Randomized Study of Imatinib Mesylate with Versus without Bevacizumab in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumor (SWOG-S0502). See the protocol summary at http://cancer.gov/clinicaltrials/SWOG-S0502.

Principal Investigators
Dr. Charles Blanke and Dr. Margaret von Mehren, Southwest Oncology Group; Dr. George Demetri, Cancer and Leukemia Group B; Dr. Vivien Bramwell, NCIC-Clinical Trials Group

Why This Trial Is Important
Gastrointestinal stromal tumors (GIST) are a type of sarcoma that usually forms in the stomach or small intestine, but it can arise anywhere in the gastrointestinal tract. About 5,000 new cases of GIST are diagnosed in the U.S. each year.

The Food and Drug Administration's approval of the drug imatinib (Gleevec) for the treatment of GIST in 2002 dramatically improved the outlook for patients with tumors that cannot be surgically removed (unresectable) or that have spread (metastatic). In previous clinical trials, imatinib helped block tumor growth in more than 80 percent of patients with advanced GIST. Unfortunately, however, patients frequently develop resistance to imatinib after an average of about 24 months.

Recent studies suggest that blocking the growth of new blood vessels (angiogenesis) may help prolong the time during which GISTs don't grow and thus prolong progression-free survival. The biological agent bevacizumab (Avastin) blocks the activity of a protein called VEGF that promotes angiogenesis. High levels of VEGF in GIST usually indicate that the cancer is more aggressive.

In this randomized trial, patients with unresectable or metastatic GIST will receive imatinib therapy with or without the addition of bevacizumab. Researchers hope that the combination of imatinib and bevacizumab will extend progression-free survival by 6 or more months.

"Imatinib works extremely well for most patients with advanced GIST, but we're trying to make it better by extending the time to imatinib resistance," said Dr. Blanke. "Additionally, we're trying to modify the imaging techniques we use to see whether the tumors are responding so that we can better determine the success of treatment for patients with GIST."

For More Information
See the lists of entry criteria and trial contact information at http://cancer.gov/clinicaltrials/SWOG-S0502 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

This trial is eligible for special Medicare coverage. See Clinical Trials Covered Under the Medicare Anti-Cancer Drug National Coverage Decision.