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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
History of Changes
  Purpose

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


Condition Intervention Phase
Prostatic Neoplasms
 Drug: docetaxel
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: January 2006
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single group Drug: docetaxel
Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280098

Locations
Czech Republic
Sanofi-Aventis
Prague, Czech Republic
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Zuzana MD Priborska Sanofi
  More Information

No publications provided

Responsible Party: Zuzana MD Priborska, Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00280098     History of Changes
Other Study ID Numbers: XRP6976J_4001
Study First Received: January 18, 2006
Last Updated: December 4, 2009
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
 Hormones
Docetaxel
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013