Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression After Local Therapy for Prostate Cancer.
- 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
- 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
up to 2.5 years (6 months therapy and 2 years of follow-up)
Susan Goodin, PharmD, FCCP, BCOP
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Karmanos Cancer Center||Detroit, Michigan 48201|
|Robert Wood Johnson University Hospital at Hamilton||Hamilton, New Jersey|
|Cooper Hospital||Camden, New Jersey 08103|