Atorvastatin and Lisinopril to Prevent Radiation-Induced Heart Disease in Cancer Patients undergoing Radiation to the Thorax, Abdomen, Chest Wall or Spine

Inclusion Criteria

• Written informed consent obtained to participate in the study and Health Insurance Portability and Accountabilty Act (HIPAA) authorization for release of personal health information
• Subjects is willing and able to comply with study procedures based on the judgement of the investigator
• Consent for serial blood draws and consent for use of biological specimens
• Age ≥ 18 years at the time of consent
• Malignancy in the thorax, abdomen, chest wall, spine anticipated to receive ≥ 25Gy EQD2 to 10% of the heart per treating physician assessment
• Subject is able to adhere to study schedule and has a prognosis that is compatible with timeline of study procedures per treating physician’s assessment (note, multimodality therapy is permitted)
• Blood urea nitrogen (BUN) ≤ 1.5 x upper limit of normal (ULN) (within 60 days prior to initiating study treatment) * Note: Hematology and other lab parameters that are ≥ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
• Potassium ≤ 1 x upper limit of normal (ULN) (within 60 days prior to initiating study treatment) * Note: Hematology and other lab parameters that are ≥ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
• Estimated glomerular filtration rate (GFR) ≥ 60 ml/min/1.73 m^2 (within 60 days prior to initiating study treatment) * Note: Hematology and other lab parameters that are ≥ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
• Bilirubin ≤ 2 x ULN (within 60 days prior to initiating study treatment) * Participants with Gilbert’s syndrome may be enrolled despite a total bilirubin level > 1.5 mg/dL if their conjugated bilirubin is < 1.5 x ULN * Note: Hematology and other lab parameters that are ≥ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
• Aspartate aminotransferase (AST) ≤ 1.5 x ULN (within 60 days prior to initiating study treatment) * Note: Hematology and other lab parameters that are ≥ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
• Alanine aminotransferase (ALT) ≤ 1.5 x ULN (within 60 days prior to initiating study treatment) * Note: Hematology and other lab parameters that are ≥ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy
• Thyroid-stimulating hormone (TSH) ≤ 4.0 mIU/L (within 60 days prior to initiating study treatment)
• Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to or at time of study enrollment * NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided
• Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 30 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label

Exclusion Criteria

• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)
• Pre-existing use of a statin or ACE-inhibitor
• Pre-existing hypotension
• Uncontrolled hyperkalemia
• Prior allergy or adverse reaction with use of a statin or ACE-inhibitor
• Contraindications to myocardial perfusion imaging (SPECT or PET per physician discretion)