Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer
This study has been terminated.
(due to celecoxib safety issues)
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00494338
First received: June 28, 2007
Last updated: September 30, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Prostate Cancer |
Drug: Docetaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- 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 [ Time Frame: two consecutive evaluations at least 4 weeks apart ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 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. ] [ Designated as safety issue: No ]
| Enrollment: | 6 |
| Study Start Date: | November 2004 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Study medical Officer, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00494338 History of Changes |
| Other Study ID Numbers: | XRP6976J_2504 |
| Study First Received: | June 28, 2007 |
| Last Updated: | September 30, 2009 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Sanofi:
|
Metastatic Androgen Independent Prostate Cancer (MAIPC) |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Docetaxel Celecoxib Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents Therapeutic Uses Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013