Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer

September 30, 2009 updated by: Sanofi

A Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer

A multi-center controlled, non-comparative open Phase II trial of docetaxel and celecoxib in patients with metastatic androgen independent prostate cancer where efficacy is measured by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients with histologically confirmed MAIPC
  • Documented progressive disease in bone, soft tissue or PSA despite castrate levels of testosterone
  • If LHRH agonist were used previously it must be kept
  • Previous anti-androgen should be held at least 4 weeks for flutamida or cyproterone and 6 weeks for bycalumida
  • Previous DES should be held for at least 4 weeks before partcipating in the trial
  • Chemotherapy naive patients
  • No prior radioisotope
  • Less than 25% of bone marrow should be irradiated for prior palliative radiotherapy
  • KPS> 70%
  • Adequate hematologic, hepatic and renal function

Exclusion Criteria:

  • Patients with serious medical illness
  • History of significant active cardiac disease
  • History of gastrointestinal ulceration, bleeding or perforation
  • History of myocardial infarctin within past 12 months
  • Allergy to sulfonamides or to celecoxib or history of urticaria to any NSAID

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of docetaxel and celecoxib by PSA response defined as a 50% reduction in PSA maintained on two consecutive evaluations at least 4 weeks apart
Time Frame: two consecutive evaluations at least 4 weeks apart
two consecutive evaluations at least 4 weeks apart

Secondary Outcome Measures

Outcome Measure
Time Frame
Response in measurable disease by response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0.
Time Frame: response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0.
response evaluation criteria in solid tumors (RECIST) criteria, time to progression, overall survival and toxicity by Natonal Cancer Institute Commum Toxicity Criteria version 2.0.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Jaderson Lima, M.D., Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

April 1, 2005

Study Completion (ACTUAL)

April 1, 2005

Study Registration Dates

First Submitted

June 28, 2007

First Submitted That Met QC Criteria

June 28, 2007

First Posted (ESTIMATE)

June 29, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2009

Last Update Submitted That Met QC Criteria

September 30, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRP6976J_2504

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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