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Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic 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: NCT00723086
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : October 1, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Therapy, Prostatic Neoplasms Drug: docetaxel (XRP6976) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Intervention Details:
  • Drug: docetaxel (XRP6976)
    combined treatment with prednisolone

Primary Outcome Measures :
  1. 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 Measures :
  1. No obvious disease progression [ Time Frame: First treatment up to 37 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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): NCT00723086

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Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00723086     History of Changes
Other Study ID Numbers: ARD6563
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009

Keywords provided by Sanofi:
docetaxel, prednisolone, drug combination

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone Acetate
Prednisolone acetate
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
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents