Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients
- Registration Number
- NCT01031628
- Brief Summary
The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- Age ≥ 18 years
- Unresectable and/or metastatic GIST
- Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
- For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
- Good physical functioning (ECOG Performance Status of 0 or 1)
- Generally, good function of organ such as liver and kidneys
- Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
- Known intolerance of imatinib at a dose of 400 mg/day or higher
- Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
- Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
- Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
- Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks or who have not recovered from side effects of this therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A Imatinib mesylate Patients with blood level less than 1100 will continue imatinib 400 mg daily Arm B Imatinib mesylate Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL Arm C Imatinib mesylate Patients with blood level ≥1100 will continue imatinib 400 mg daily Arm D Imatinib mesylate Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily
- Primary Outcome Measures
Name Time Method Evaluation of Lesions for Progression or Response Via RECIST Criteria Every 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Sarcoma Oncology Center
🇺🇸Santa Monica, California, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Cedars-Sinai Outpatient Cancer Center
🇺🇸Los Angeles, California, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Carolinas Hematology Oncology Associates
🇺🇸Charlotte, North Carolina, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington Cancer Institute
🇺🇸Washington, District of Columbia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States