Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 27
- Locations
- 4
- Primary Endpoint
- PSA Response
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Atorvastatin and Celecoxib
Intervention: atorvastatin calcium (Drug)
Atorvastatin and Celecoxib
Intervention: celecoxib (Drug)
Atorvastatin and Celecoxib
Intervention: laboratory biomarker analysis (Other)
Outcomes
Primary Outcomes
PSA Response
Time Frame: 6 months
PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.
Secondary Outcomes
No secondary outcomes reported
Investigators
Susan Goodin, PharmD
Professor of Medicine, RWJMS
Rutgers, The State University of New Jersey