Gastrointestinal Stromal Tumor Clinical Trial
Official title:
A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors
RATIONALE: Imatinib mesylate and sunitinib may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate
given together with sunitinib in treating patients with gastrointestinal stromal tumors.
OBJECTIVES:
- To determine the maximum tolerated dose of imatinib mesylate in combination with
sunitinib malate in patients with gastrointestinal stromal tumors.
- To determine the toxicity of this regimen in these patients.
- To determine the antitumor activity in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral sunitinib malate once daily on days 1-14 in course 1 and on days 1-42
in all subsequent courses. Beginning in course 2, patients also receive oral imatinib
mesylate once or twice daily on days 1-42. Courses repeat every 6 weeks in the absence of
unacceptable toxicity.
Blood samples are collected on day 15 and day 43 for pharmacokinetics.
After completion of study treatment, patients are followed every 6 months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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