Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028769
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2002-01-04
Brief Title:
S0032 Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Evaluation of Early Oral Estramustine Oral Etoposide and Intravenous Paclitaxel in Combination With Hormone Therapy in Patients With High-Risk Metastatic Adenocarinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2013-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Androgens can stimulate the growth of prostate cancer cells Drugs such as goserelin leuprolide flutamide or bicalutamide may stop the adrenal glands from producing androgens Combining chemotherapy with hormone therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus hormone therapy in treating patients who have metastatic prostate cancer
Detailed Description:
OBJECTIVES
Determine the progression-free and overall survival in patients with high-risk metastatic adenocarcinoma of the prostate treated with early estramustine etoposide and paclitaxel with combined androgen-blockade therapy
Determine the type frequency and severity of toxicity of this regimen in this patient population
OUTLINE This is a multicenter study
Androgen-blockade therapy Patients receive a standard regimen of luteinizing hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously once monthly or once every 3 months or leuprolide intramuscularly once monthly once every 3 months or once every 4 months Patients also receive a standard regimen of antiandrogen therapy comprising oral bicalutamide oral flutamide or oral nilutamide once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Chemotherapy Beginning 14-30 days after initiation of androgen-blockade therapy patients receive oral estramustine three times daily and oral etoposide once daily on days 1-14 and paclitaxel IV over 1 hour on day 2 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 2 years
Determine the progression-free and overall survival in patients with high-risk metastatic adenocarcinoma of the prostate treated with early estramustine etoposide and paclitaxel with combined androgen-blockade therapy
Determine the type frequency and severity of toxicity of this regimen in this patient population
OUTLINE This is a multicenter study
Androgen-blockade therapy Patients receive a standard regimen of luteinizing hormone-releasing hormone agonist therapy comprising either goserelin subcutaneously once monthly or once every 3 months or leuprolide intramuscularly once monthly once every 3 months or once every 4 months Patients also receive a standard regimen of antiandrogen therapy comprising oral bicalutamide oral flutamide or oral nilutamide once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Chemotherapy Beginning 14-30 days after initiation of androgen-blockade therapy patients receive oral estramustine three times daily and oral etoposide once daily on days 1-14 and paclitaxel IV over 1 hour on day 2 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 80 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0032 | OTHER | None | None |