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

Phase 2

Terminated

• Conditions: Metastatic Prostate Cancer

• Registration Number: NCT00494338
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-30
• Last Update Posted: 2009-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 6

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	two consecutive evaluations at least 4 weeks apart

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Sanofi-Aventis; 🇧🇷 Sao Paulo, Brazil