Phase III Randomized, Intergroup Trial Assessing The Clinical Activity Of STI-571 At Two Dose Levels In Patients With Unresectable Or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing The KIT Receptor Tyrosine Kinase (CD117)
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
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 24 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall survival (OS)
Up to 3 years
Southwest Oncology Group
United States: Food and Drug Administration
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