Phase II Trial to Evaluate Benefit of Early Switch from first-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the opposite sequence, exploring molecular markers and mechanisms of taxane resistance in men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who have not received prior chemotherapy
To determine if there is a benefit on prostate cancer to switch from Docetaxel/prednisone to Cabazitaxel/prednisone and the opposite sequence in men who had not received prior chemotherapy.
-Adequate kidney function and liver function as seen on labs. -Progressive disease while receiving hormone therapy by either increase in measurable disease on CT scan, appearance of 2 or more lesions on bone scan or Rise in PSA of 2 values in a row at least 1 week apart. - Testosterone level must be less than 50ng/dL. -Must be off antiandrogens for 4-6 weeks. -Must be off finasteride or dutasteride for at least 4 weeks. -No prior chemotherapy except adjuvant/neoadjuvant treatment completed at least 3 years ago. -If on bisphosphonates, must be at least for 12 weeks.
Patients will be openly randomized to receive either Docetaxel 75mg/m2 every 21 days for 4 cycles first or Cabazitaxel 25mg/m2 every 21 days for 4 cycles. After 4 cycles the PSA is checked and if it shows a reduction of 30% the patient stays on designated drug. If the PSA rises or does not show a 30% reduction the patient will be switched to the opposide drug from the one they were receiving for the remainder of the study. Scans are rechecked after Cycle 3 and Cycle 6 and then every 12 weeks. Patients will also take Prednisone 5mg twice a day with both drugs and will complete a pain diary before each visit.
12/21/2013 04:02 AM