Clinical trial · Interventional
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
NCT00494338CI-TRIAL-00002679terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to celecoxib safety issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- timeFrame
- two consecutive evaluations at least 4 weeks apart
Secondary outcomes (1)
- 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.
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.