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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00038168 |
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 | Intervention | Phase |
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Prostate Cancer |
Drug: Estramustine Drug: Taxol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Intravenous Estramustine Phosphate Combined With Taxol in Patients With Hormone Refractory Adenocarcinoma of the Prostate |
Estimated Enrollment: | 58 |
Study Start Date: | June 2000 |
Estimated Study Completion Date: | January 2003 |
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.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Study ID Numbers: | DM98-268 |
Study First Received: | May 29, 2002 |
Last Updated: | November 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00038168 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prostate Cancer |
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Estramustine Urogenital Neoplasms Antimitotic Agents Genital Diseases, Male Hormones Carcinoma |
Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Adenocarcinoma Antineoplastic Agents, Phytogenic Alkylating Agents Prostatic Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Mitosis Modulators Estramustine Urogenital Neoplasms Antimitotic Agents Genital Diseases, Male Pharmacologic Actions |
Carcinoma Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Alkylating Adenocarcinoma Antineoplastic Agents, Phytogenic Alkylating Agents Prostatic Neoplasms Neoplasms, Glandular and Epithelial |