(HealthDay)—A phase I trial of dasatinib combined with paclitaxel and carboplatin has determined the optimal dose of dasatinib and suggested some efficacy in women with advanced or recurrent ovarian cancer, according to research published in the Oct. 1 issue of Clinical Cancer Research.
As part of a phase I trial, Angeles Alvarez Secord, M.D., from the Duke University Medical Center in Durham, N.C., and colleagues treated a total of 20 patients with advanced and recurrent epithelial ovarian cancer with escalating doses of dasatinib (100, 120, and 150 mg daily), combined with paclitaxel and carboplatin.
The researchers found that concurrent administration of dasatinib with paclitaxel did not significantly alter the effects of either dasatinib or paclitaxel. Grade 3 or 4 toxicities included myalgia, neutropenia, thrombocytopenia, and fatigue. Eight patients achieved complete or partial remission, 10 patients had stable disease, and two patients could not be evaluated. The median progression-free survival was 7.8 months and the median overall survival was 16.2 months. No biomarker could be identified to determine which patients would benefit from dasatinib.
"Due to the high incidence of myelosuppression with subsequent cycles, the recommended phase II dose of dasatinib is 150 mg daily in combination with paclitaxel and carboplatin," Secord and colleagues conclude. "The combination was safe with evidence of clinical activity."
The study was partially supported by a research grant from Bristol-Myers Squibb.
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