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Sponsors and Collaborators: |
Sanofi-Aventis Canadian Urologic Oncology Group |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00268710 |
Primary objectives:
Secondary objectives:
Condition | Intervention | Phase |
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Prostatic Neoplasms |
Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC) |
Study Start Date: | February 2004 |
Study Completion Date: | March 2006 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory requirements :
Hematology:
Hepatic function:
Renal function:
Exclusion Criteria
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | XRP6976J/2503 |
Study First Received: | December 21, 2005 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00268710 History of Changes |
Health Authority: | Canada: Health Canada |
Docetaxel Prednisone Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms |
Docetaxel Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Antineoplastic Agents |
Therapeutic Uses Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Pharmacologic Actions |