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Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00280098
First received: January 18, 2006
Last updated: December 4, 2009
Last verified: December 2009

January 18, 2006
December 4, 2009
January 2006
October 2007   (final data collection date for primary outcome measure)
  • PSA decline [ Time Frame: after each docetaxel administration and after the end of treatment ] [ Designated as safety issue: No ]
  • pain response [ Time Frame: after each docetaxel administration and after the end of treatment ]
  • side effects occurrence [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00280098 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Docetaxel in the Treatment of Hormone Refractory Prostate Cancer
Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment

Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostatic Neoplasms
Drug: docetaxel
Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid
Experimental: single group
Intervention: Drug: docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
October 2007   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00280098
XRP6976J_4001
Not Provided
Zuzana MD Priborska, Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Zuzana MD Priborska Sanofi
Sanofi
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP