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

Study Overview
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Brief Summary
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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.

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

Conditions
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Metastatic Prostate Cancer

Intervention / Treatment
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* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Androgen Independent Prostate Cancer (MAIPC)