Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma

Prostate Cancer Clinical Trial

Official title: Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00038168
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2000
• Completion date: January 2003