Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

Phase IV Study of Safety and Efficacy of Docetaxel in Combination With Prednisone in Advanced Hormone Refractory Prostate Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280098
• Other study ID #: XRP6976J_4001
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2006
• Last updated: December 4, 2009
• Start date: January 2006

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter :

Inclusion Criteria:

• Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2

Exclusion Criteria:

• Other cytostatic treatment, other malignity, severe comorbidity

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• docetaxel
Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid

Locations

Country	Name	City	State
Czech Republic	Sanofi-Aventis	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA decline		after each docetaxel administration and after the end of treatment	No
Primary	pain response		after each docetaxel administration and after the end of treatment
Primary	side effects occurrence		Throughout the study	Yes