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

• Status: Terminated
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Androgens; Celecoxib; Docetaxel

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.