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

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Metastatic Prostate Cancer

Treatments: Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494338

XRP6976J_2504

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)