Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer
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.
Drug: atorvastatin calcium
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.|
- PSA response [ Time Frame: up to 2.5 years (6 months therapy and 2 years of follow-up) ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
|Experimental: Atorvastatin and Celecoxib||Drug: atorvastatin calcium Drug: celecoxib Other: laboratory biomarker analysis|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220973
|United States, Michigan|
|Karmanos Cancer Center|
|Detroit, Michigan, United States, 48201|
|United States, New Jersey|
|Camden, New Jersey, United States, 08103|
|Robert Wood Johnson University Hospital at Hamilton|
|Hamilton, New Jersey, United States, 08690|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Susan Goodin, PharmD, FCCP, BCOP||Rutgers Cancer Institute of New Jersey|