Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer
Phase 2
Completed
- Conditions
- Therapy, Prostatic Neoplasms
- Registration Number
- NCT00723086
- Lead Sponsor
- Sanofi
- Brief Summary
The purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
Patients who completed the 10 cycles of docetaxel administrations in the preceding XRP6976J/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the Investigator's judgment.
Exclusion Criteria
- Continuation in the study would be detrimental to the patient's well-being
- Development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing
- Obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion)
- Patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the XRP6976J/2101 study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0) First treatment up to 37 months
- Secondary Outcome Measures
Name Time Method No obvious disease progression First treatment up to 37 months
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇯🇵Tokyo, Japan