Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038168
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2002-05-29
Brief Title:
Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Phase I The goal of this clinical research study is to find the highest dose of estramustine phosphate administered intravenously in combination with a fixed dose of Taxol paclitaxel that can be given safely to participants with prostate cancer who have failed to further benefit from hormone treatment
Phase II The goal of this clinical research study is to find out if the combination of the drugs estramustine phosphate and paclitaxel will shrink or control prostate cancer that has not responded to hormone treatment A second goal is to find out if the side effects of these drugs can be reversed The safety of these drugs will also be studied
Phase II The goal of this clinical research study is to find out if the combination of the drugs estramustine phosphate and paclitaxel will shrink or control prostate cancer that has not responded to hormone treatment A second goal is to find out if the side effects of these drugs can be reversed The safety of these drugs will also be studied
Detailed Description:
To determine the maximum tolerated dose of intravenous estramustine phosphate combined with Taxol
To estimate the complete and partial response rates to treatments with intravenous estramustine phosphate combined with Taxol in the treatment of hormone-refractory adenocarcinoma of the prostate
To determine the qualitative and quantitative toxicity of the combination of intravenous estramustine phosphate and Taxol
To estimate the complete and partial response rates to treatments with intravenous estramustine phosphate combined with Taxol in the treatment of hormone-refractory adenocarcinoma of the prostate
To determine the qualitative and quantitative toxicity of the combination of intravenous estramustine phosphate and Taxol
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