Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165399
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2005-09-09
Brief Title:
Docetaxel Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Local Treatment
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Docetaxel Estramustine and Short Term Androgen Withdrawal for Patients With a Rising PSA After Definitive Local Treatment
Status:
COMPLETED
Status Verified Date:
2018-06
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 see if the combination of chemotherapy drugs and drugs to suppress testosterone hormone therapy is effective in controlling early prostate cancer
This study will attempt to
stop or slow the growth of disease
gain information about prostate cancer
evaluate the effectiveness and side effects of the study drug
This study will attempt to
stop or slow the growth of disease
gain information about prostate cancer
evaluate the effectiveness and side effects of the study drug
Detailed Description:
Patients will receive two medications docetaxel and estramustine Estramustine will be taken orally three times daily for 5 days starting on day one Docetaxel will be given intravenously on day 2 These two drugs will be repeated every 3 weeks for a total of 4 cycles 12 weeks
Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects
Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots
After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment Three weeks after the last chemotherapy treatment patients will start Casodex orally once daily
After taking Casodex for 1 week patients will then start on Zoladex an injection in the abdomen every 3 months for a total of 5 injections
During study treatment various blood tests will be performed to watch the disease Study treatment will stop after a total of 18 months 3 months chemotherapy and 15 months hormone therapy A physical exam and blood tests will be performed every 3 months for 2 years every 4 months for the third year and then every 6 months after that
Patients will also take dexamethasone for three days at the beginning of each cycle to help decrease the risk of side effects
Patients will also take coumadin every day for three months while on the chemotherapy to reduce the risk of blood clots
After 12 weeks the chemotherapy phase will be completed and patient will start on the hormone therapy part of the treatment Three weeks after the last chemotherapy treatment patients will start Casodex orally once daily
After taking Casodex for 1 week patients will then start on Zoladex an injection in the abdomen every 3 months for a total of 5 injections
During study treatment various blood tests will be performed to watch the disease Study treatment will stop after a total of 18 months 3 months chemotherapy and 15 months hormone therapy A physical exam and blood tests will be performed every 3 months for 2 years every 4 months for the third year and then every 6 months after that
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