Status:
COMPLETED
Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Pfizer
Beth Israel Deaconess Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 pr...
Detailed Description
This study is designed as a randomized, double blind, placebo-controlled study. These are all scientific research methods used to protect the study from personal bias or prejudice. Patients who parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00136487
Start Date
October 1 2002
End Date
September 1 2006
Last Update
December 9 2009
Active Locations (9)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
Faulkner Hospital
Boston, Massachusetts, United States, 02130