Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Beth Israel Deaconess Medical Center
Emerson Hospital
Brigham and Women's Hospital
Hartford Hospital
Lowell General Hospital
Massachusetts General Hospital
M.D. Anderson Cancer Center
University of Michigan Cancer Center
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00136487
First received: August 26, 2005
Last updated: December 7, 2009
Last verified: December 2009
  Purpose

The purpose of this study is to learn the effects (both good and bad) that celecoxib has on prostate cancer and patients with prostate cancer. This study is looking at what effects celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate cancer. An increase or decrease in this level in the blood can indicate if a patient's prostate cancer is getting worse or better.


Condition Intervention Phase
Prostate Cancer
Drug: Celecoxib
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib Versus Placebo in Men With Prostate Cancer With Rising PSA Following Prostatectomy or Radiation Therapy

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group

Secondary Outcome Measures:
  • To compare changes in PSADT between the first and second six-month treatment periods for those in the placebo-treated group
  • to correlate COX-2 expression in the patients' original prostate samples with biologic activity of celecoxib (when feasible)
  • to correlate changes in plasma vascular endothelial growth factor (VEGF) levels in patients with biologic activity of celecoxib

Estimated Enrollment: 85
Study Start Date: October 2002
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of prostate cancer
  • Progression following prostatectomy or radiation to the prostate, defined as 3 PSA rises, with each PSA determination at least 4 weeks apart
  • PSA greater than or equal to 1.0 for men who had a prostatectomy
  • PSA greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy)
  • PSA doubling time between 6 and 24 months
  • Participants must be either fully active and asymptomatic or symptomatic but fully ambulatory
  • Adequate bone marrow function, kidney function and liver function as evidenced by laboratory results

Exclusion Criteria:

  • Evidence of metastatic disease
  • Prior hormonal therapy for recurrent prostate cancer
  • Prior chemotherapy for recurrent or metastatic prostate cancer
  • Radiation therapy within 6 months
  • Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other NSAIDs
  • Patients taking a dose of aspirin greater than or equal to 325 mg a day within 4 weeks of study entry
  • Patients taking selective COX-2 inhibitors or any NSAIDs other than aspirin within 8 weeks of study entry
  • Patients taking fluconazole, lithium or warfarin
  • History of gastrointestinal or abdominal ulceration or any history of significant gastrointestinal bleeding in the past 12 months
  • Any history of myocardial infarction in the past 12 months
  • Any uncontrolled, serious medical or psychiatric illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136487

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Faulkner Hospital
Boston, Massachusetts, United States, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Emerson Hospital
Concord, Massachusetts, United States, 01742
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Dana-Farber Cancer Institute
Pfizer
Beth Israel Deaconess Medical Center
Emerson Hospital
Brigham and Women's Hospital
Hartford Hospital
Lowell General Hospital
Massachusetts General Hospital
M.D. Anderson Cancer Center
University of Michigan Cancer Center
Investigators
Principal Investigator: Philip W. Kantoff, MD Dana-Farber Cancer Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136487     History of Changes
Other Study ID Numbers: 02-193, COXAON-0509-125
Study First Received: August 26, 2005
Last Updated: December 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Prostate Cancer
Cancer of Prostate
Cancer of the Prostate
Prostate-Specific Antigen

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014