Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089609
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2004-08-06
Brief Title:
Docetaxel Thalidomide Prednisone and Bevacizumab to Treat Metastatic Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Trial of Docetaxel Thalidomide Prednisone and Bevacizumab in Patients With Androgen-Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-03
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:
This is a Phase II study of docetaxel bevacizumab prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy The primary objective of this study is to determine if the combination of docetaxel thalidomide and bevacizumab is able to be associated with a sufficiently high proportion of patients with a prostate-specific antigen PSA response to be worthy of further investigation in metastatic prostate cancer We will also be looking at multiple secondary endpoints These will include possible pharmacokinetic interactions among the study agents potential correlation between patient genotype and efficacy of treatment We will also be looking for circulating tumor cells in blood before and after treatment Additionally we will be monitoring the tolerability of the regimen and survival duration as endpoints as well We hope to use this trial to build on the promising results seen in our thalidomidedocetaxel protocol where there was a significant PSA decline and a trend toward survival benefit
Detailed Description:
This is a Phase II study of docetaxel bevacizumab prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy The primary objective of this study is to determine if the combination of docetaxel thalidomide and bevacizumab is able to be associated with a sufficiently high proportion of patients with a PSA response to be worthy of further investigation in metastatic prostate cancer We will also be looking at multiple secondary endpoints These will include possible pharmacokinetic interactions among the study agents potential correlation between patient genotype and efficacy of treatment We will also be looking for circulating endothelial cells in blood before and after treatment Additionally we will be monitoring the tolerability of the regimen time to disease progression and survival duration as endpoints as well We hope to use this trial to build on the promising results seen in our thalidomidedocetaxel protocol where there was a significant PSA decline and a trend toward survival benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-C-0257 | None | None | None |