Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer
NCT ID: NCT00494338
Last Updated: 2009-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
6 participants
INTERVENTIONAL
2004-11-30
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Docetaxel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Jaderson Lima, M.D.
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
São Paulo, , Brazil
Countries
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Other Identifiers
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XRP6976J_2504
Identifier Type: -
Identifier Source: org_study_id
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