Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268710
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2005-12-21
Brief Title:
Docetaxel in Hormone Refractory Prostate Cancer HRPCWeekly or 3weekly TAX Prednisone in HRPC
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Multicenter Phase II Study of Taxotere Docetaxel Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer HRPC
Status:
COMPLETED
Status Verified Date:
2009-12
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:
Primary objectives
To determine the response rate measurable and non measurable to Taxotere in the second line setting
Secondary objectives
To evaluate the overall safety and toxicity of Taxotereprednisone combination as second line therapy in HRPC
To evaluate PSA response PSA Prostate Specific Antigen
To evaluate symptomatic response
To evaluate Quality of life
To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere
To determine the response rate measurable and non measurable to Taxotere in the second line setting
Secondary objectives
To evaluate the overall safety and toxicity of Taxotereprednisone combination as second line therapy in HRPC
To evaluate PSA response PSA Prostate Specific Antigen
To evaluate symptomatic response
To evaluate Quality of life
To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere
Detailed Description:
None
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