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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
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).
Biomedicum Helsinki
Helsinki, Finland
Institut Bergonie
Bordeaux, France
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 8 more locations