Spots Global Cancer Trial Database for Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

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Trial Identification

Brief Title: Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors

Official Title: A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors

Study ID: NCT00573404

Conditions

Gastrointestinal Stromal Tumor

Interventions

imatinib mesylate

sunitinib malate

pharmacological study

Study Description

Brief Summary: 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.

Detailed Description: 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.