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

This study has been completed.

First Received on August 26, 2005. Last Updated on December 7, 2009 History of Changes

Sponsor:	Dana-Farber Cancer Institute
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

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 II Phase III

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

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

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
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012