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Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00280098
Recruitment Status : Completed
First Posted : January 20, 2006
Last Update Posted : December 7, 2009
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Brief Summary:
Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: docetaxel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2006
Actual Primary Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: single group Drug: docetaxel
Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid

Primary Outcome Measures :
  1. PSA decline [ Time Frame: after each docetaxel administration and after the end of treatment ]
  2. pain response [ Time Frame: after each docetaxel administration and after the end of treatment ]
  3. side effects occurrence [ Time Frame: Throughout the study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00280098

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Czech Republic
Prague, Czech Republic
Sponsors and Collaborators
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Study Director: Zuzana MD Priborska Sanofi

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Responsible Party: Zuzana MD Priborska, Study Director, sanofi-aventis Identifier: NCT00280098    
Other Study ID Numbers: XRP6976J_4001
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal