Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00514917 |
To evaluate and compare the efficacy of androgen deprivation with or without Docetaxel as determined by the median progression free survival (PFS) within the period of 18 months of therapy and at least 18 months follow-up.
Condition | Intervention | Phase |
---|---|---|
Prostatic Neoplasms |
Drug: Docetaxel Drug: Leuprolide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy |
Estimated Enrollment: | 412 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm A: Active Comparator
Docetaxel 75 mg/m2 q 3 weeks for 10 cycles; Leuprolide 22.5 mg q 3 months x 18 months; Bicalutamide 50 mg x 4 weeks;
|
Drug: Docetaxel
Docetaxel 75 mg/m2 q 3 weeks for 10 cycles Leuprolide 22.5 mg q 3 months x 18 months Bicalutamide 50 mg x 4 weeks
|
Arm B: Active Comparator
Leuprolide 22.5 mg q 3 months x 18 months; Bicalutamide 50 mg x 4 weeks;
|
Drug: Leuprolide
Leuprolide 22.5 mg q 3 months x 18 months; Bicalutamide 50 mg x 4 weeks;
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Inclusion Criteria:
Subjects must meet all of the following criteria:
Adequate organ function as defined by the following laboratory criteria:
AST and ALT and Alkaline Phosphatase must be within the range as indicated below. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Radiographic findings suspicious for metastatic disease in the treating physician's clinical judgment.
Patients who had radiographically suspicious pelvic lymph nodes prior to radial prostatectomy, but who, at the time of registration to the trial doe not have suspicious adenopathy (for example, either because those nodes were resected or were irradiated post-operative are eligible. Patients are eligible even if they had tumor-containing pelvic adenopathy at the time of surgery as long as at the time of registration they do not have radiographically evident nodal disease in the clinician's opinion.
Contact: Public Registry MA US | PublicRegistryUSMA@sanofi-aventis.com |
United States, New Jersey | |
Sanofi-aventis Administrative Office | Recruiting |
Bridgewater, New Jersey, United States | |
Belgium | |
Sanofi-aventis Administrative Office | Not yet recruiting |
Diegem, Belgium | |
Canada | |
Sanofi-aventis Administrative Office | Recruiting |
Québec, Canada | |
Croatia | |
Sanofi-aventis Administrative Office | Withdrawn |
Zagreb, Croatia | |
Czech Republic | |
Sanofi-aventis Administrative Office | Recruiting |
Praha, Czech Republic | |
Finland | |
Sanofi-aventis Administrative Office | Withdrawn |
Helsinki, Finland | |
Germany | |
Sanofi-aventis Administrative Office | Recruiting |
Frankfurt, Germany | |
Lithuania | |
Sanofi-aventis Administrative Office | Recruiting |
Vilnius, Lithuania | |
Poland | |
Sanofi-aventis Administrative Office | Recruiting |
Warsaw, Poland | |
Slovakia | |
Sanofi-aventis Administrative Office | Recruiting |
Bratislava, Slovakia | |
Spain | |
Sanofi-aventis Administrative Office | Recruiting |
Barcelona, Spain | |
Ukraine | |
Sanofi-aventis Administrative Office | Withdrawn |
Kiev, Ukraine |
Study Director: | Vicki Erickson, MSN | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( Study Director ) |
Study ID Numbers: | XRP6976J_3503, EudraCT#:2007-000323-17 |
Study First Received: | August 2, 2007 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00514917 History of Changes |
Health Authority: | United States: Institutional Review Board |
Docetaxel Antineoplastic Agents, Hormonal Prostatic Diseases Genital Neoplasms, Male Leuprolide |
Bicalutamide Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Androgens |
Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Reproductive Control Agents Genital Diseases, Male Pharmacologic Actions |
Docetaxel Neoplasms Neoplasms by Site Leuprolide Fertility Agents, Female Therapeutic Uses Fertility Agents Prostatic Neoplasms |