Clinical Trials

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
• Subjects must have histologically confirmed high grade ovarian, fallopian tube, or primary peritoneal carcinoma of serous histology (any of these three are referred to in this protocol as “ovarian cancer”)
• Incurable cancer
• Willingness to provide paraffin-embedded tissue blocks of ovarian cancer
• Measurable disease
• Obtained =< 14 days prior to registration: Absolute neutrophil count (ANC) >= 1500 uL
• Obtained =< 14 days prior to registration: Platelet (PLT) >= 100,000 uL
• Obtained =< 14 days prior to registration: Hemoglobin (Hgb) >= 9 g/dL
• Obtained =< 14 days prior to registration: Total bilirubin =< 1.5 x upper limit of normal (ULN) or direct bilirubin =< ULN
• Obtained =< 14 days prior to registration: Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN or SGOT (AST) and SGPT (ALT) =< 5 x ULN is acceptable if liver has tumor involvement
• Obtained =< 14 days prior to registration: Creatinine =< 1.5 x ULN
• Obtained =< 14 days prior to registration: Fasting serum glucose =< 1.5 x ULN
• Obtained =< 14 days prior to registration: Total cholesterol =< 1.5 x ULN
• Obtained =< 14 days prior to registration: Triglycerides =< 1.5 x ULN
• Life expectancy >= 12 weeks

Exclusion Criteria:

• Platinum-sensitive disease (exceptions allowed: patient has had a hypersensitivity reaction to platinum or the treating oncologist thinks that further platinum therapy is not in the patient?s best interest)
• Morbidities or concurrent major illness (for example, bowel obstruction or a second active malignancy) that, in the opinion of the treating healthcare provider, would make participation in the trial problematic
• Leptomeningeal disease or uncontrolled brain metastasis
• Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment
  • NOTE: Patients can have peripheral (sensory) neuropathy
• History of hypertriglyceridemia or hypercholesterolemia and currently on medication(s)
• Use of St. John's wort =< 7 days prior to registration
• Unable to discontinue use of a strong CYP3A4 inhibitor