Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer
This study has been completed.
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
First received: August 26, 2005
Last updated: December 7, 2009
Last verified: December 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 23, 2013