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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Male

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 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Emerson Hospital, Concord, MA; Hartford Hospital; Lowell General Hospital; M.D. Anderson Cancer Center; Massachusetts General Hospital; Pfizer; University of Michigan Cancer Center; University of Michigan Rogel Cancer Center
• Treatments: Celecoxib

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