Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT00073970|
Recruitment Status : Terminated (Study stopped due to increased cardiovascular risks associated with Celebrex)
First Posted : December 11, 2003
Last Update Posted : May 23, 2012
RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor and by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who have relapsed prostate cancer following radiation therapy or radical prostatectomy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: celecoxib||Phase 2|
- Determine the effect of celecoxib on prostate-specific antigen (PSA) levels in patients with prostate cancer in biochemical relapse after prior definitive radiotherapy or radical prostatectomy.
- Compare the PSA doubling times in patients treated with this drug vs historical controls.
- Compare the PSA doubling times in patients treated with this drug vs pretreatment PSA values.
- Determine the time to clinical recurrence in patients treated with this drug.
OUTLINE: Patients receive oral celecoxib twice daily. Treatment continues for 5 years in the absence of disease progression. Patients may continue treatment beyond 5 years at the discretion of the treating physician.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||January 2006|
- Drug: celecoxib
400mg, given twice dailyOther Name: Celebrex
- Effect of COX-2 inhibitors on PSA level [ Time Frame: 9 months ]To study the effect of COX-2 inhibitors on PSA level in patients who have only biochemical relapse after definitive radiation therapy or surgery for prostate cancer. In particular, to study the effect of celecoxib on PSA levels and PSA doubling times as compared to 1) historical controls (known and well-described median PSA doubling times of 9 months), and 2) pre-treatment PSA values and doubling times.
- Disease progression rate [ Time Frame: 5 years ]Progression will be defined as evidence of biochemical relapse (increase in serum PSA levels on 3 successive determinations, provided that the increase is at least 5 ng/ml from baseline) or clinical objective progression or relapse - i.e. the development of new lesions by digital rectal exam (DRE) or enlargement of existing lesion, or the development of symptoms of clinical progression (specifically bony pain) which is confirmed by radiological imaging studies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073970
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7235|
|Study Chair:||Raj S. Pruthi, MD||UNC Lineberger Comprehensive Cancer Center|