Clinical Trial: Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase I Study of Imatinib Mesylate and SU011248 for Patients With Gastrointestinal Stromal Tumors
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 Summary:
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.
Sponsor: Vanderbilt-Ingram Cancer Center
Current Primary Outcome: Maximum tolerated dose of imatinib mesylate in combination with sunitinib malate [ Time Frame: at 6 weeks ]
Original Primary Outcome: Maximum tolerated dose of imatinib mesylate in combination with sunitinib malate
Current Secondary Outcome:
- Toxicity profile as assessed by NCI CTCAE v3.0 [ Time Frame: every 6 weeks ]
- Pharmacokinetics [ Time Frame: days 15 & 43 ]
- Preliminary data on anti-tumor activity of these drugs as assessed by RECIST [ Time Frame: 18 weeks ]
Original Secondary Outcome:
- Toxicity profile as assessed by NCI CTCAE v3.0
- Pharmacokinetics
- Preliminary data on anti-tumor activity of these drugs as assessed by RECIST
Information By: Vanderbilt-Ingram Cancer Center
Dates:
Date Received: December 13, 2007
Date Started: July 2007
Date Completion:
Last Updated: November 12, 2011
Last Verified: November 2011