Dasatinib as First-Line Therapy in Treating Patients With Gastrointestinal Stromal Tumors
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial|
- Response as assessed by fusion PET/CT scan according to EORTC PET Study Group criteria [ Time Frame: at 4 weeks compared to baseline ]
- Best response as assessed by CT scan/MRI [ Time Frame: according to RECIST criteria ]
- Best response as assessed by fusion PET/CT scan [ Time Frame: at 4 weeks ]
- Clinical benefit [ Time Frame: Clinical benefit is defined as CR, PR, or as SD lasting at least 12 weeks, determined according to RECIST ]
- Time to progression [ Time Frame: calculated from registration until progression or death due to tumor ]
- Progression-free survival [ Time Frame: calculated from registration until progression or death ]
- Time to treatment failure [ Time Frame: calculated from registration until premature trial treatment termination due to any reason ]
- Overall survival [ Time Frame: Overall survival will be calculated from registration until death or last follow-up, up to 5 years. ]
- Adverse drug reactions according to NCI CTCAE v3.0 [ Time Frame: Tolerability will be assessed based on the frequency and severity of Adverse Drug Reactions (ADR) coded according to NCI CTCAE v3.0. ]
|Actual Study Start Date:||December 2007|
|Estimated Study Completion Date:||December 2018|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Dasatinib is given orally 70 mg BID. Dasatinib will be continued until progression, unacceptable toxicity and up to 2 years (26 cycles, each cycle lasting 4 weeks).
Other Name: Sprycel
- To determine the efficacy of dasatinib as assessed by fusion PET/CT scan in patients with gastrointestinal stromal tumors.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568750
|Helsinki, Finland, FI-00290|
|Bordeaux, France, 33076|
|Hopital Edouard Herriot - Lyon|
|Lyon, France, 69437|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Essen, Germany, D-45122|
|Baden, Switzerland, CH-5404|
|Saint Claraspital AG|
|Basel, Switzerland, CH-4016|
|Basel, Switzerland, CH-4031|
|Bruderholz, Switzerland, CH-4101|
|Chur, Switzerland, CH-7000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Liestal, Switzerland, CH-4410|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Onkozentrum - Klinik im Park|
|Zurich, Switzerland, 8002|
|City Hospital Triemli|
|Zurich, Switzerland, CH-8063|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Michael Montemurro, MD||Centre Hospitalier Universitaire Vaudois|