NCT00073970

Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy

A Trial Of COX-2 Inhibitors In PSA Recurrence After Definitive Radiation Or Radical Prostatectomy For Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	celecoxib	400mg, given twice daily

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-06-01
• Completion: 2006-01-01
• First posted: 2003-12-11
• Last updated: 2012-05-23

Locations

1 site across 1 country: United States