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Completed

NCT Number: NCT00723086

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

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.

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Key information

Conditions

Therapy, Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel (XRP6976)

Drug

combined treatment with prednisolone

Primary outcomes

  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 outcomes

  1. No obvious disease progression

    Time frame: First treatment up to 37 months

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 28, 2008
Registry last updated
Oct 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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