NCT01220973

Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Atorvastatin calcium and celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atorvastatin calcium together with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving atorvastatin calcium together with celecoxib works in treating patients with rising PSA levels after local therapy for prostate cancer.

Detailed description

OBJECTIVES: Primary * To determine the effect on the biological activity, as assessed by prostate-specific antigen (PSA) response, of atorvastatin calcium and celecoxib in patients with D0 prostate cancer. Secondary * To document the safety and feasibility of atorvastatin calcium and celecoxib in patients with early-stage prostate cancer. * To evaluate the effects of the combination of atorvastatin calcium and celecoxib on nuclear factor-kB (NFkB), extracellular signal-regulated kinase (ERK), prostaglandin E2 (PGE2), and IL6 in peripheral blood mononuclear cells (PBMC). OUTLINE: This is a multicenter study. Patients receive oral atorvastatin calcium once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo blood sample collection at baseline and after completion of study therapy for correlative studies. After completion of study therapy, patients are followed up every 3 months for 2 years.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	atorvastatin calcium
DRUG	celecoxib
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-11-18
• Completion: 2014-11-18
• First posted: 2010-10-14
• Last updated: 2018-06-08
• Results posted: 2018-04-20

Locations

4 sites across 1 country: United States