Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136526
Status:
COMPLETED
Last Update Posted:
2013-05-09
First Post:
2005-08-25
Brief Title:
Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer A Phase II Study
Status:
COMPLETED
Status Verified Date:
2013-05
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:
This study is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy This study is designed to determine if a new drug combination will help to control the cancer The medicines being used docetaxel and diethylstilbestrol DES have been given to patients with prostate cancer and each drug has demonstrated activity in prostate cancer either used alone or in other combinations The objective of this study is to determine the effect of this drug combination on the prostate cancer and its response to disease progression
Detailed Description:
This is a single arm phase II trial of docetaxel and diethylstilbestrol for patients with symptomatic stage D3 androgen independent prostate cancer Patients will receive docetaxel weekly for 10 cycles each cycle consists of treatment for 3 weeks out of every 4 and DES daily for 40 weeks or until there is evidence of disease progression whichever occurs first Patients will be followed to determine PSA and objective response Additional endpoints include time to progression disease specific survival and overall survival Disease progression will be defined as 2 consecutive increases in PSA andor tumor growth as evidenced by examination or radiologic evaluation Other secondary objectives will be to determine the toxicity and impact on quality of life of this regimen
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FHCRC-UW-02-4599-V | None | None | None |