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:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00494338
First received: June 28, 2007
Last updated: September 30, 2009
Last verified: September 2009
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00494338

Locations
Brazil
Sanofi-Aventis
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima, M.D. Sanofi
  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 April 17, 2014