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