Statement: According to the results of the primary trial the MTD of dasatinib in combination with weekly paclitaxel is approximately is 120 mg.
Primary_evidence: Outcome Measurement:    Phase I Portion: Maximum Tolerated Dose/MTD of Dasatinib When Administered in Combination With a Fixed Dose of Weekly Paclitaxel.   [Not Specified]   Time frame: Through completion of Phase I, up to 1 year Results 1:    Arm/Group Title: Dasatinib and Paclitaxel   Arm/Group Description: The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. Between 6 and 54 patients will likely be necessary to determine the MTD of dasatinib in combination with weekly paclitaxel.   The phase II portion of this trial has a Simon two-stage design to determine the efficacy of dasatinib when administered in combination with paclitaxel.   Dasatinib and Paclitaxel: A treatment cycle will consist of 28 days, according to the following schedule:   Dasatinib 120MG PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.   The trial will initially test the combination of weekly paclitaxel and dasatinib given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort (0), the next cohort will test dasatinib given with a different schedule, 5 days on and 2 days off, omitting dasatinib the day prior and the day of administration of paclitaxel.   Overall Number of Participants Analyzed: 15   Measure Type: Number   Unit of Measure: mg of dasatinib  120