Atorvastatin for Preventing Disease Metastasis in Patients With Resected High-Risk Stage IIA, IIB, or IIIA Melanoma

PRIMARY OBJECTIVE: I. To compare recurrence-free survival (RFS) of patients with high-risk melanoma treated with atorvastatin to placebo. SECONDARY OBJECTIVES: I. To compare distant metastasis-free survival (DMFS) between treatment arms. II. To compare overall survival (OS) between treatment arms. EXPLORATORY OBJECTIVE: I. To assess the clinical utility of gene expression profiling in melanoma. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive placebo orally (PO) once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study. ARM II: Patients receive atorvastatin PO once per day in the absence of disease progression or unacceptable toxicity for up to 5 years and CT and/or MRI throughout the study. After completion of study treatment, patients are followed for 5 years.