Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate|
- Response Rate [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2000|
|Study Completion Date:||January 2003|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
|Experimental: Estramustine + Taxol||
Other Name: Estramustine phosphateDrug: Taxol
Other Name: Paclitaxel
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.