Prostate Cancer Clinical Trial
Official title:
Phase II Trial of Atorvastatin and Celecoxib in Patients With Hormone-Dependent Prostate-Specific Antigen Progression 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.
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.
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