Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251225
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2005-11-08
Brief Title:
A Study of Imatinib and Docetaxel in Prostate Cancer
Sponsor:
Leonard Appleman
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Phase II Study of Imatinib and Docetaxel in Metastatic Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 determine the effectiveness of two drugs docetaxel and Gleevecalso called imatinib in prostate cancer that no longer responds to hormone therapy The investigators are interested in finding out if the combination of these two drugs is more effective than docetaxel alone in the treatment of prostate cancer
Detailed Description:
This is a non-randomized multicenter Phase II trial of Gleevec and docetaxel in chemo naïve metastatic hormone refractory prostate cancer The primary objective of this study is to assess the time to disease progression in patients with hormone refractory prostate cancer treated with daily oral imatinib and intravenous docetaxel administered every three weeks Secondary objectives include 1 to assess the rate of response to imatinib and docetaxel using Prostate Specific Antigen PSA andor measurable disease 2 to assess the overall survival of patients with hormone refractory prostate cancer treated with imatinib and docetaxel and 3 to evaluate the qualitative and quantitative toxicities of this combination
Study Oversight
Has Oversight DMC:
None
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?:
None