Targeting Immune Modulation in High Grade Serous Carcinoma: Combined Effects of Chemotherapy and Atorvastatin

Prior treatment

• History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1).
• Prior or current statin use that would prohibit randomization into SOC arm.
• Planned treatment with bevacizumab in the primary treatment setting.

Other illness

• Significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within the past 3 months, unstable arrhythmia, or unstable angina.
• Known central nervous system (CNS) malignancy or CNS metastases.
• Patients with previous malignancy within the past 2 years from cycle 1, day 1, except those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast.
• Patients with duodenal stent or other gastrointestinal (GI) disorder/defect that would interfere with absorption of oral medication.
  • o Includes patients unable to swallow orally administered medication and patients with GI disorders likely to interfere with absorption of the study medication

Lab values

• Known clinically significant liver disease defined as AST and ALT \> 3.0 x ULN and/or total bilirubin ≥ 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease.
• Medical history of untreated HIV infection. Patients with medical history of HIV infection are eligible provided they meet following criteria
  • Are stable on antiretroviral therapy for ≥4 weeks before randomization
  • Agree to adhere to antiretroviral therapy per World Health Organization (WHO) guidelines
  • Have no documented multi-drug resistance that would prevent effective antiretroviral therapy
  • Have a viral load of \<400 copies per mL at screening
  • Have CD4+ T cell count at ≥ 350 cells per μL
  • Have no history of acquired immunodeficiency syndrome (AIDS) -defining opportunistic infection ≤ 12 months before randomization.

Other

• Inability to comply with study and follow-up procedures.
• Participation in investigational clinical trial within last 30 days.
• Inability to provide informed consent.
• Patients with prognosis for survival less than 6 months.
• Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion.
• Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing.
• Patients who are currently pregnant or lactating.
• Diagnosis based on ascites assessment only and not a tissue biopsy.
• Patients deemed otherwise clinically unfit for clinical trial per investigators discretion

• Be a patient with ovarian cancer aged 18-89
• Diagnosed via tissue biopsy not ascites
• For persons of reproductive potential, use of highly effective method(s) of contraception.
• Patients with primary Stage III/IV high-grade serous ovarian/fallopian tube/primary peritoneal cancer not amenable to upfront cytoreductive surgery.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
• Absolute Neutrophil Count 1500 cells/mL
• Platelet count \> 100,000 mL.
• Hemoglobin 9.0 g/dL
• Serum albumin ³ 2.5 g/dL.
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
• aspartate aminotransferase (AST )and alanine aminotransferase (ALT) ≤ 3.0 x ULN.
• Serum creatinine ≤ 1.5x ULN