Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

NCT ID: NCT00280098

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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

Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single group

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid

Interventions

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docetaxel

Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Zuzana MD Priborska

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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XRP6976J_4001

Identifier Type: -

Identifier Source: org_study_id

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