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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Sanofi-Aventis |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00811031 |
Purpose
Objectives:
Primary:
Secondary:
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Taxotere Drug: Prednisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer |
| Estimated Enrollment: | 28 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Taxotere + Prednisone |
Drug: Taxotere
75 mg/m^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.
Other Name: docetaxel
Drug: Prednisone
5 mg twice a day by mouth.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Lance Pagliaro, MD, BA / Associate Professor, UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00811031 History of Changes |
| Other Study ID Numbers: | 2008-0045 |
| Study First Received: | December 16, 2008 |
| Last Updated: | September 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Prostate prostate gland prostate cancer markers Taxotere® |
Docetaxel Prednisone Castration Resistant Prostate Cancer adenocarcinoma of the prostate |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Prednisone Docetaxel |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |