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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Phase III Randomized Study of Imatinib Mesylate With Versus Without Bevacizumab in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI	SWOG-S0502 S0502, CALGB-S0502, CAN-NCIC-S0502, NCT00324987

Special Category: NCI - CMS pilot project trial, NCI Web site featured trial, CTSU trial

Trial Description

Purpose:

Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate together with bevacizumab may kill more tumor cells. It is not yet known whether imatinib mesylate and bevacizumab are more effective than imatinib mesylate alone in treating gastrointestinal stromal tumor.

This randomized phase III trial is studying imatinib mesylate and bevacizumab to see how well they work compared to imatinib mesylate alone in treating patients with metastatic or unresectable gastrointestinal stromal tumor.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastasis
• At least 4 weeks since chemotherapy, radiation therapy, or surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive imatinib mesylate by mouth once a day for 3 weeks. They will also receive a 30- to 90-minute infusion of bevacizumab once in week 1. Treatment may repeat every 3 weeks for as long as benefit is shown.

Patients in group two will receive imatinib mesylate by mouth once a day. Treatment may continue for as long as benefit is shown.

Blood samples* will be taken periodically for laboratory studies.

 [Note: *Samples are no longer considered mandatory for study as of 5/29/2009.]

After finishing treatment, patients will be evaluated periodically for up to 7 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Blanke, MD, FACP, Protocol chair		Ph: 604-877-6098 ext. 2738 Email: cblanke@bccancer.bc.ca
Margaret von Mehren, MD, Protocol co-chair		Ph: 215-728-3545; 888-369-2427

Cancer and Leukemia Group B

George Demetri, MD, Protocol chair		Ph: 617-632-3985; 866-790-4500 Email: gdemetri@partners.org

NCIC-Clinical Trials Group

Vivien Bramwell, MB, BS, PhD, FRCP, Protocol chair		Ph: 403-521-3707

Related Information

Featured trial article

Registry Information
Official Title		A Phase III Randomized Study of Imatinib, With or Without Bevacizumab (NSC-704865), in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors
Trial Start Date		2008-04-15
Trial Completion Date		2014-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00324987
Date Submitted to PDQ		2006-04-18
Information Last Verified		2009-09-23
NCI Grant/Contract Number		CA32102

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