Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer
A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib Versus Placebo in Men With Prostate Cancer With Rising PSA Following Prostatectomy or Radiation Therapy
2 other identifiers
interventional
85
1 country
9
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 prostate-cancer
Started Oct 2002
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 26, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedDecember 9, 2009
December 1, 2009
3.9 years
August 26, 2005
December 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Pfizercollaborator
- Beth Israel Deaconess Medical Centercollaborator
- Emerson Hospital, Concord, MAcollaborator
- Brigham and Women's Hospitalcollaborator
- Hartford Hospitalcollaborator
- Lowell General Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
- M.D. Anderson Cancer Centercollaborator
- University of Michigan Rogel Cancer Centercollaborator
Study Sites (9)
Hartford Hospital
Hartford, Connecticut, 06102, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Faulkner Hospital
Boston, Massachusetts, 02130, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Emerson Hospital
Concord, Massachusetts, 01742, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip W. Kantoff, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 26, 2005
First Posted
August 29, 2005
Study Start
October 1, 2002
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
December 9, 2009
Record last verified: 2009-12