Status:
TERMINATED
Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Ovarian Serous Tumor
Recurrent Ovarian Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the overall tumor response rate (ORR, that is, complete response \[CR\] + partial response \[PR\]) of the combination of auranofin and sirolimus in the setting of m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03456700
Start Date
March 30 2018
End Date
July 31 2019
Last Update
May 8 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905