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

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

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.

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.