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

Metastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00494338
• Other study ID #: XRP6976J_2504
• Status: Terminated
• Phase: Phase 2
• First received: June 28, 2007
• Last updated: September 30, 2009
• Start date: November 2004
• Est. completion date: April 2005

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Docetaxel

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No