Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
Condition: Ovarian Serous Tumor; Recurrent Ovarian Carcinoma
Intervention: Auranofin; Laboratory Biomarker Analysis; Sirolimus
Intervention description: Given PO; Correlative studies; Given PO
Intervention MeSH terms: Sirolimus; Auranofin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well auranofin and sirolimus work in treating participants
      with ovarian cancer. Immunosuppressive therapy, such as auranofin and sirolimus, is used to
      decrease the body?s immune response and may increase blood cell count.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

          -  Ovarian, Fallopian Tube or Primary Peritoneal cancer of serous histology

          -  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