Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083005
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2004-05-14
Brief Title:
Docetaxel Estramustine and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial Combining Estramustine Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
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 such as docetaxel and estramustine work in different ways to stop tumor cells from dividing so they stop growing or die Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor Giving chemotherapy together with thalidomide may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma cancer of the prostate
PURPOSE This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma cancer of the prostate
Detailed Description:
OBJECTIVES
Primary
Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel estramustine and thalidomide
Secondary
Determine the survival duration in patients treated with this regimen
Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen
Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel andor thalidomide and clinical activity or toxicity of this regimen in these patients
Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen
Determine genotype with regard to cytochrome P450 2C19 polymorphism in patients treated with this regimen
Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients
Determine the changes in molecular markers of angiogenesis including but not limited to serum and urine vascular endothelial growth factor in patients before and after treatment with this regimen
Determine the toxicity profile of this regimen in these patients
OUTLINE This is an open-label study
Patients receive docetaxel IV over 30 minutes on days 2 9 and 16 oral thalidomide once daily on days 1-28 and oral estramustine three times daily on days 1-3 8-10 and 15-17 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 33-60 patients will be accrued for this study within 11-20 months
Primary
Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel estramustine and thalidomide
Secondary
Determine the survival duration in patients treated with this regimen
Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen
Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel andor thalidomide and clinical activity or toxicity of this regimen in these patients
Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen
Determine genotype with regard to cytochrome P450 2C19 polymorphism in patients treated with this regimen
Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients
Determine the changes in molecular markers of angiogenesis including but not limited to serum and urine vascular endothelial growth factor in patients before and after treatment with this regimen
Determine the toxicity profile of this regimen in these patients
OUTLINE This is an open-label study
Patients receive docetaxel IV over 30 minutes on days 2 9 and 16 oral thalidomide once daily on days 1-28 and oral estramustine three times daily on days 1-3 8-10 and 15-17 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 33-60 patients will be accrued for this study within 11-20 months
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 |
|---|---|---|---|
| CDR0000361758 | None | None | None |
| 04-C-0132 | None | None | None |