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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Cancer and Leukemia Group B NCIC Clinical Trials Group |
| Information provided by: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00324987 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Biological: bevacizumab Drug: imatinib mesylate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Study of Imatinib, With or Without Bevacizumab (NSC-704865), in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors |
| Estimated Enrollment: | 572 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral imatinib mesylate once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days.
|
Biological: bevacizumab
Given IV
Drug: imatinib mesylate
Given orally
|
|
Active Comparator: Arm II
Patients receive oral imatinib mesylate once daily on days 1-21. Courses repeat every 21 days.
|
Drug: imatinib mesylate
Given orally
|
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0 vs 1-3) and disease status (measurable vs non-measurable). Patients are randomized to 1 of 2 treatment arms.
Blood* is obtained at baseline, periodically during study treatment, and at disease progression. Blood* is analyzed for angiogenesis-related soluble factors, kinase genotyping, pharmacokinetics, and pharmacogenomics.
NOTE: *Samples are no longer considered mandatory for study as of 5/29/2009.
After completion of study treatment, patients are followed periodically for up to 7 years.
PROJECTED ACCRUAL: A total of 572 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastrointestinal stromal tumor (GIST)
Metastatic or unresectable disease
PATIENT CHARACTERISTICS:
No contraindication to oral medications (e.g., severe dysphagia)
No other prior malignancy except for any of the following:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior radiotherapy
No prior bevacizumab or other agents targeting vascular endothelial growth factor (VEGF), VEGF receptor, or platelet-derived growth factor receptor (PDGFR) for advanced disease
No concurrent therapeutic warfarin for anticoagulation
Contacts and Locations
Show 239 Study Locations| Study Chair: | Charles D. Blanke, MD, FACP | British Columbia Cancer Agency |
| Study Chair: | Margaret von Mehren, MD | Fox Chase Cancer Center |
| Study Chair: | George D. Demetri, MD | Dana-Farber Cancer Institute |
| Study Chair: | Vivien H.C. Bramwell, MB,PhD,FRCP | Tom Baker Cancer Centre - Calgary |
More Information
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00324987 History of Changes |
| Other Study ID Numbers: | CDR0000482236, U10CA032102, S0502, CALGB-S0502, CAN-NCIC-S0502 |
| Study First Received: | May 10, 2006 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Imatinib Bevacizumab Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |