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Japanese Study of the Combined Administration of Docetaxel With Prednisolone for Metastatic Hormone Refractory Prostate Cancer

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 24, 2008
Last updated: September 30, 2009
Last verified: September 2009
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 Intervention Phase
Therapy, Prostatic Neoplasms Drug: docetaxel (XRP6976) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

Enrollment: 16
Study Start Date: May 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: docetaxel (XRP6976)
    combined treatment with prednisolone

Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00723086

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

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00723086     History of Changes
Other Study ID Numbers: ARD6563
Study First Received: July 24, 2008
Last Updated: September 30, 2009

Keywords provided by Sanofi:
docetaxel, prednisolone, drug combination

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisolone acetate
Methylprednisolone 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 processed this record on July 19, 2017