A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel
Docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant
prostate cancer (CRPC) but duration of response is limited, with median time to
prostate-specific antigen (PSA) progression of 6-8 months. There is currently no standard
second-line therapy for patients who have progressed after receiving docetaxel. Carboplatin
and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this
regimen are limited. In addition, correlative studies investigating why some patients
respond are lacking.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in prostate-specific antigen (PSA) level
Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.
Himisha Beltran, M.D.
Weill Medical College of Cornell University
United States: Institutional Review Board
|Weill Cornell Medical Collgeg||New York, New York 10021|