Ovarian Cancer Clinical Trial
Official title:
A Phase I Trial of A SRC Kinase Inhibitor, Dasatinib,in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Recurrent Ovarian, Peritoneal, and Tubal Cancer
Primary objective to determine the maximal tolerated (MTD) of dasatinib in combination with
paclitaxel and carboplatin during the first cycle of treatment.
Secondary objectives to describe the toxicity of this combination of therapy; to describe
the pharmacokinetics and pharmacodynamics parameters related to this combination; to
describe the clinical activity as defined as the response rate (complete and partial
response rate) and progression-free survival > 6 month; to compare the SRC pathway
microarray signature in pre and post-treatment cancer specimens; to evaluate SRC pathway
downstream substrates, FAX, paxcillin, and CRK-L in pre and post-treatment cancer specimens.
This is a phase I multicenter study designed to determine the maximal tolerated dose (MTD) and toxicity of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment in patients with advanced or recurrent ovarian, peritoneal, and tubal carcinoma. The MTD will be defined as the highest dose at which no more than 1 of 6 evaluable patient experiences a dose-limiting toxicity (DLT) due to the combination of dasatinib, paclitaxel,and carboplatin during the first cycle of treatment. ;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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