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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: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer |
| Estimated Enrollment: | 28 |
| Study Start Date: | September 2009 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Taxotere + Prednisone: Experimental |
Drug: Taxotere
75 mg/m^2 Day 1 of every 21-day cycle by vein for 4 cycles prior to surgery.
Drug: Prednisone
5 mg twice a day by mouth.
|
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| Contact: Paul Mathew, MD | 713-792-2830 |
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Paul Mathew, MD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Paul Mathew ) |
| Study ID Numbers: | 2008-0045 |
| Study First Received: | December 16, 2008 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00811031 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Prostate prostate gland prostate cancer markers Taxotere® |
Docetaxel Prednisone Castration Resistant Prostate Cancer adenocarcinoma of the prostate |
|
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Glucocorticoids Hormones Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |