Intravenous Estramustine With Taxol in Hormone Refractory Prostate Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT00038168|
Recruitment Status : Completed
First Posted : May 30, 2002
Last Update Posted : August 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Estramustine Drug: Taxol||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||January 2003|
|Actual Study Completion Date :||January 2003|
|Experimental: Estramustine + Taxol||
Other Name: Estramustine phosphate
Other Name: Paclitaxel
- Response Rate [ Time Frame: Study Completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038168
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Jeri Kim, M.D.||UT MD Anderson Cancer Center|