Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
- Registration Number
- NCT00568750
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.
- Detailed Description
OBJECTIVES:
Primary
* To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors.
Secondary
* To determine the efficacy and safety of dasatinib in these patients.
* To correlate the efficacy of dasatinib with KIT and PDGFR mutational status.
* To correlate the efficacy and safety of dasatinib with dasatinib drug exposure.
* To determine the efficacy of second-line treatment with another TK-inhibitor.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 4 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dasatinib dasatinib -
- Primary Outcome Measures
Name Time Method Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria at 4 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Best response as assessed by CT scan/MRI according to RECIST criteria Progression-free survival calculated from registration until progression or death Overall survival Overall survival will be calculated from registration until death or last follow-up, up to 5 years. Time to progression calculated from registration until progression or death due to tumor Time to treatment failure calculated from registration until premature trial treatment termination due to any reason Adverse drug reactions according to NCI CTCAE v3.0 Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0. Clinical benefit Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST Best response as assessed by fusion PET/CT scan at 4 weeks
Trial Locations
- Locations (18)
Biomedicum Helsinki
🇫🇮Helsinki, Finland
Institut Bergonie
🇫🇷Bordeaux, France
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Kantonsspital Baden
🇨🇭Baden, Switzerland
Saint Claraspital AG
🇨🇭Basel, Switzerland
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
Kantonsspital Bruderholz
🇨🇭Bruderholz, Switzerland
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