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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00514540 |
Purpose
The goal of this clinical research study is to learn about how effective 2 different schedules of chemotherapy drugs (Paraplatin [carboplatin] plus Taxotere [docetaxel] and VePesid [etoposide] plus Platinol-AQ [cisplatin]) are in the treatment of patients with anaplastic prostate cancer. The safety of both therapy combinations will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Docetaxel Drug: Carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma |
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Carboplatin + Docetaxel |
Drug: Docetaxel
75 mg/m^2 IV Over 60 Minutes On Day 1 Repeat Every 3 Weeks.
Other Name: Taxotere
Drug: Carboplatin
AUC = 5, IV Over 30 Minutes On Day 1 Repeat Every 3 Weeks.
Other Name: Paraplatin
|
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| United States, California | |
| University of California-San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Ana M. Aparicio, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00514540 History of Changes |
| Other Study ID Numbers: | 2006-0097 |
| Study First Received: | August 9, 2007 |
| Last Updated: | November 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Prostate Cancer Anaplastic Prostate Cancer Carboplatin |
Docetaxel Taxotere Paraplatin |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Docetaxel Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |