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

Original Study ID : XRP6976J-2504

NCT ID : 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

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.

Source : Sanofi-Aventis

Overall Status : Terminated

Start Date : November 2004

Official Title : Phase 2

Phase : Interventional

Study Design : Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Enrollment : 6

Verification Date : June 2007

First Received Date : June 28, 2007

Trial 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.

Gender : Male

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Sanofi-Aventis

City : Sao Paulo

Country : Brazil

OutComes

Primary OutComes

Measure : 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 OutComes

Measure : 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.

Interventions

Type : Drug

Name : Docetaxel

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