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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
Weill Cornell Medical College
New York, New York, United States
Change in Prostate-specific Antigen (PSA) Level
Time frame: Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.
Change in Tumor Size
Assessed by CT or MRI scan and/or bone scan.
Time frame: Baseline, week 12, week 24 and end of study.
Change in Survival Status
Time frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.
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