Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT01220973
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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).
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Atorvastatin and Celecoxib celecoxib - Atorvastatin and Celecoxib atorvastatin calcium - Atorvastatin and Celecoxib laboratory biomarker analysis -
- Primary Outcome Measures
Name Time Method PSA Response 6 months PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Cooper Hospital
🇺🇸Camden, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Karmanos Cancer Center
🇺🇸Detroit, Michigan, United States
Robert Wood Johnson University Hospital at Hamilton
🇺🇸Hamilton, New Jersey, United States