Conditions: Prostate Cancer
Keywords: Metastatic Castrate Resistant Prostate Cancer CRPC
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief summary:
The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.

Detailed description:
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.

Arms:
arm 1: Carboplatin and Paclitaxel

Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel
Intervention descriptions: intervention 1: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle intervention 2: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle

Protocol document: