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

• Sponsor: Sanofi (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00723086
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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 1, 2005
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Outcome Measures

Primary Outcome Measures

1. Incidence rate of adverse events on each grade evaluated by National Cancer Institute Common Toxicity Criteria (Version 2.0) [First treatment up to 37 months]

Secondary Outcome Measures

1. No obvious disease progression [First treatment up to 37 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Tokyo		Japan

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: ICD CSD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00723086
• Other Study ID Numbers: ARD6563; XRP6976J/2102
• First Posted: Jul 28, 2008
• Last Update Posted: Oct 1, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: docetaxel, prednisolone, drug combination
• Additional relevant MeSH terms: Prostatic Neoplasms; Docetaxel

Study Results

No Results Posted as of Oct 1, 2009