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

This study has been completed.

First Received: July 24, 2008 Last Updated: October 16, 2008 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00723086

Purpose

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Docetaxel Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

No obvious disease progression [ Time Frame: First treatment up to 37 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
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:

combined treatment with prednisolone

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723086

Locations

Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	ARD6563, XRP6976J/2102
Study First Received:	July 24, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00723086 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

docetaxel, prednisolone, drug combination

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Genital Neoplasms, Male
Prostatic Diseases
Methylprednisolone
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Urogenital Neoplasms

Prednisolone acetate
Genital Diseases, Male
Neuroprotective Agents
Glucocorticoids
Hormones
Docetaxel
Prednisolone
Peripheral Nervous System Agents
Prostatic Neoplasms
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prostatic Diseases
Genital Neoplasms, Male
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Urogenital Neoplasms
Neuroprotective Agents
Hormones
Docetaxel
Neoplasms by Site
Therapeutic Uses

Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Methylprednisolone acetate
Genital Diseases, Male
Protective Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009