Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/mÂ² and at 25 mg/mÂ² Every 3 Weeks in Combination with Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen.
The main purpose of this study is to determine if the Cabazitaxel dose of 20 mg/m2 is better tolerated and still as effective as the Cabazitaxel dose of 25 mg/m2.
Patients must have histologically or cytologically confirmed prostate cancer. They must have previously be determined to have resistance to hormone therapy and have had been treated previously with a docetaxel-containing therapy and must have disease progression. Must have adequate kidney/liver functions, and adequate bone marrow function. Cannot have previous uncontrolled cardiac hypertension, or history of congestive heart failure, or MI within the last 6 months. Cannot have had surgery, radiation, chemotherapy or other anti-cancer therapy within 4 weeks prior to enrollment. Cannot have brain metastasis.
The patient will be randomized to one of two arms: Arm A is Cabazitaxel 20 mg/m2 IV on day 1 of a 21 day cycle plus prednisone 10 mg taken orally daily. Arm B is Cabazitaxel 25 mg/m2 IV on day 1 of a 21 day cycle plus prednisone 10 mg orally daily.
12/06/2013 04:02 AM