Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 10:52 PM
Study NCT ID:
NCT01558492
Status:
TERMINATED
Last Update Posted:
2017-06-09
First Post:
2012-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: