Docetaxel in the Treatment of Hormone Refractory Prostate... | NCT00280098

Studies
Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

NCT00280098

Sponsor

Sanofi

Status

Completed

Last Update Posted

Dec 7, 2009Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Prostatic Neoplasms

Interventions

docetaxel

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Not provided

First Submitted Date

Jan 18, 2006

First Submission Date that Met QC Criteria

Jan 18, 2006

First Posted Date

Jan 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2009

Last Update Posted Date

Dec 7, 2009Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single group	Experimental		Drug: docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
docetaxel	Drug	Docetaxel 75mg/m2/q3wx10 cycles with Prednisone 10mg/d/bid	single group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PSA decline		after each docetaxel administration and after the end of treatment
pain response		after each docetaxel administration and after the end of treatment
side effects occurrence		Throughout the study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Zuzana MD Priborska	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077143	Docetaxel

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided