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Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic Cancer

NCT00541281 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-10-27

No results posted yet for this study

Summary

we propose to randomize patients with hormone resistant prostate cancer between docetaxel/estramustine/prednisone and docetaxel/prednisone in a phase II study. The principal endpoint will be the efficacy in term of PSA response.

Conditions

Interventions

DRUG

docetaxel

35mg/m² on day 2 and 9 (21days in a cycle)

DRUG

estramustine

140mg caps x3 bid from day 1to 5 and day 8 to 12 of each cycle

DRUG

prednisone

2x5 mg a day

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Jean-Pascal Machiels, MD PHD · Cliniques Universitaires St Luc

  • Joseph Kerger, MD · Clinqiue Universitaire de Mont Godinne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Completion
2006-02-28

Countries

  • Belgium
  • Luxembourg

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00541281 on ClinicalTrials.gov