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Refining Treatment for Gastrointestinal Stromal Tumors
Untitled Document
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.
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.
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Dr. Charles Blanke
Principal Investigator |
Why This Trial Is Important
Gastrointestinal stromal tumor (GIST) is 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 FDA'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 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.
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