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

Primary Purpose

Metastatic Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Docetaxel
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring Metastatic Androgen Independent Prostate Cancer (MAIPC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 28, 2007
Last Updated
September 30, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00494338
Brief Title
Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer
Official Title
A Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Terminated
Why Stopped
due to celecoxib safety issues
Study Start Date
November 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
Metastatic Androgen Independent Prostate Cancer (MAIPC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Docetaxel
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson Lima, M.D.
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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