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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Therapy, Prostatic Neoplasms

Treatments: Drug: docetaxel (XRP6976)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00723086

ARD6563

XRP6976J/2102

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)