Ovarian Cancer Clinical Trial
Auranofin and Sirolimus in Treating Participants With Ovarian Cancer
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.
Full 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 metastatic serous ovarian cancer across all patients.
SECONDARY 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 metastatic serous ovarian cancer within patients that have overexpression of PKCiota.
II. To estimate progression-free survival, overall survival, and adverse events from the combination of auranofin and sirolimus.
CORRELATIVE OBJECTIVES:
I. To explore whether PKCiota-relevant biomarkers in serous ovarian cancer tumors are associated with treatment response patterns, such as ORR, progression free survival, and overall survival.
OUTLINE:
Participants receive auranofin orally (PO) once daily (QD) and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, participants are followed up every 6 months for 3 years.
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
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There is 1 Location for this study
Rochester Minnesota, 55905, United States
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