Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046826
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2002-10-03
Brief Title:
Docetaxel Estramustine and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
Sponsor:
Nuvance Health
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Clinical Trial of Taxotere Emcyt and Thalidomide TET for the Treatment of Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2006-01
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 Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with thalidomide may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy
PURPOSE Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel estramustine and thalidomide
Determine the safety and toxicity of this regimen in these patients
Determine the efficacy of this regimen for pain control in these patients
OUTLINE Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity
Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 1 year
Determine the objective response rate in patients with hormone-refractory prostate cancer treated with docetaxel estramustine and thalidomide
Determine the safety and toxicity of this regimen in these patients
Determine the efficacy of this regimen for pain control in these patients
OUTLINE Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day 2 for 3 weeks Treatment repeats every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity
Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed monthly until disease progression
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V01-1681 | None | None | None |
| NH-0139 | None | None | None |