Back to resultsJapanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer
Primary Purpose
Therapy, Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
docetaxel (XRP6976)
Sponsored by
About this trial
This is an interventional treatment trial for Therapy, Prostatic Neoplasms focused on measuring docetaxel, prednisolone, drug combination
Eligibility Criteria
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
Sites / Locations
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0)
Secondary Outcome Measures
No obvious disease progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00723086
Brief Title
Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer
Official Title
An Extension Multicenter Phase II Open Label Non-comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Therapy, Prostatic Neoplasms
Keywords
docetaxel, prednisolone, drug combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
docetaxel (XRP6976)
Intervention Description
combined treatment with prednisolone
Primary Outcome Measure Information:
Title
Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0)
Time Frame
First treatment up to 37 months
Secondary Outcome Measure Information:
Title
No obvious disease progression
Time Frame
First treatment up to 37 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer
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