CClinicalTrials.gg
TerminatedNCT00494338Updated Oct 1, 2009

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

A Phase 2 interventional study of Docetaxel in Metastatic Prostate Cancer, sponsored by Sanofi. Terminated at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-01.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Why this study was terminated
due to celecoxib safety issues
Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Metastatic Prostate Cancer

Browse trials for

Keywords

  • Metastatic Androgen Independent Prostate Cancer (MAIPC)
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 6 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Interventions

  • DrugDocetaxel
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

07

Study locations

1 site
  • Sanofi-Aventis
    Sao Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00494338
Lead sponsor
Sanofi
First posted
Jun 29, 2007
Start date
Nov 2004
Primary completion
Apr 2005
Completion
Apr 2005
Last update
Oct 1, 2009

Study contacts

Jaderson Lima, M.D.
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion