Back to resultsDocetaxel in the Treatment of Hormone Refractory Prostate Cancer
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
Eligibility Criteria
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. Main criteria are listed hereafter : Inclusion Criteria: Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2 Exclusion Criteria: Other cytostatic treatment, other malignity, severe comorbidity
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single group
Arm Description
Outcomes
Primary Outcome Measures
PSA decline
pain response
side effects occurrence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00280098
Brief Title
Docetaxel in the Treatment of Hormone Refractory Prostate Cancer
Official Title
Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
Brief Summary
Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid
Primary Outcome Measure Information:
Title
PSA decline
Time Frame
after each docetaxel administration and after the end of treatment
Title
pain response
Time Frame
after each docetaxel administration and after the end of treatment
Title
side effects occurrence
Time Frame
Throughout the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Main criteria are listed hereafter :
Inclusion Criteria:
Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2
Exclusion Criteria:
Other cytostatic treatment, other malignity, severe comorbidity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuzana MD Priborska
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Prague
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
Docetaxel in the Treatment of Hormone Refractory Prostate Cancer
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