Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260611
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2005-11-29
Brief Title:
Study of Oxaliplatin and Taxotere in Prostate Cancer
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Study of Oxaliplatin and Taxotere in Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-03
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 primary objective for this study is to evaluate PSA response rates response will be defined as a 50 reduction in PSA levels in men who have failed primary chemotherapy The secondary objectives are to compare progression free survival disease free survival overall survival and toxicity tolerancesafety
Detailed Description:
This is a single institution phase II study of oxaliplatin and Taxotere in patients with androgen independent prostate cancer previously treated with up to two cytotoxic chemotherapy regimens During this study the efficacy and safety of this combination will be evaluated The primary objective for this study is to evaluate PSA response rates response will be defined as a 50 reduction in PSA levels in men who have failed primary chemotherapy The secondary objectives are to compare progression free survival disease free survival overall survival and toxicity tolerancesafety There will be up to 35 male subjects 18 years of age enrolled on this single institution study
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