Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer
Completed · Phase 2/Phase 3
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00136487
- Run by
- Dana-Farber Cancer Institute
- People needed
- 85
- Starts
- 2002-10-01
- Expected to finish
- 2006-09-01
- Last updated by the study team
- 2009-12-09
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hartford Hospital — Hartford, Connecticut, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Faulkner Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Emerson Hospital — Concord, Massachusetts, United States
- Lowell General Hospital — Lowell, Massachusetts, United States
- University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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