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


Phase 2
18 Years
N/A
Not Enrolling
Male
Metastatic Prostate Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

two consecutive evaluations at least 4 weeks apart

Safety Issue:

No

Principal Investigator

Jaderson Lima, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Brazil: National Health Surveillance Agency

Study ID:

XRP6976J_2504

NCT ID:

NCT00494338

Start Date:

November 2004

Completion Date:

April 2005

Related Keywords:

  • Metastatic Prostate Cancer
  • Metastatic Androgen Independent Prostate Cancer (MAIPC)
  • Prostatic Neoplasms

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