Imatinib Mesylate and Sunitinib in Treating Patients With Gastrointestinal Stromal Tumors
- Conditions
- Gastrointestinal Stromal Tumor
- Interventions
- Registration Number
- NCT00573404
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Therapeutic Intervention imatinib mesylate - Therapeutic Intervention pharmacological study - Therapeutic Intervention sunitinib malate -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of imatinib mesylate in combination with sunitinib malate at 6 weeks
- Secondary Outcome Measures
Name Time Method Toxicity profile as assessed by NCI CTCAE v3.0 every 6 weeks Pharmacokinetics days 15 & 43 Preliminary data on anti-tumor activity of these drugs as assessed by RECIST 18 weeks
Trial Locations
- Locations (3)
Vanderbilt-Ingram Cancer Center - Cool Springs
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
🇺🇸Nashville, Tennessee, United States