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

NCT00494338 | Terminated Phase 2

• 1 other identifier: XRP6976J_2504
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic Androgen Independent Prostate Cancer (MAIPC)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Docetaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

São Paulo, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jaderson Lima, M.D.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: November 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: October 1, 2009

Record last verified: 2009-09

Locations

BR (1)