Randomized phase III trial to compare the effectiveness of two different doses of STI571 in treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571 may interfere with the growth of tumor cells and may be an effective treatment for cancer. It is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal tumors.
PRIMARY OBJECTIVES: I. Compare the overall and progression-free survival of patients with CD117-expressing metastatic or unresectable gastrointestinal stromal tumor treated with two different doses of imatinib mesylate. II. Compare the confirmed, unconfirmed, complete, and partial response rates in patients treated with these regimens. III. Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral imatinib mesylate once daily. Arm II: Patients receive oral imatinib mesylate twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients in arm I with progressive disease may cross over to arm II and receive treatment in the absence of further disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
748
Given orally
Overall survival (OS)
Time frame: Up to 3 years
Progression-free survival
Time frame: From date of registration to date of first observation of progressive disease or death due to any cause, assessed up to 3 years
Toxicity defined as any grade 3 or greater organ toxicity, or any grade 4 or greater hematological toxicity as assessed by CTCAE version 2.0
Time frame: Up to 3 year after completion of treatment
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Western Regional CCOP
Phoenix, Arizona, United States
University of Arizona Health Sciences Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Highlands Oncology Group-Rogers
Rogers, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Long Beach Community Hospital
Long Beach, California, United States
University of Southern California/Norris Cancer Center
Los Angeles, California, United States
University of California at Los Angeles Health System
Los Angeles, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
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