Phase II Trial to Evaluate the Efficacy of Auranofin and Sirolimus in Serous Ovarian Cancer Patients With Recurrent Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (auranofin, sirolimus)
Participants receive auranofin PO QD and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
干预措施: Auranofin (Drug)
Treatment (auranofin, sirolimus)
Participants receive auranofin PO QD and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (auranofin, sirolimus)
Participants receive auranofin PO QD and sirolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity.
干预措施: Sirolimus (Drug)
结局指标
主要结局
Number of Participants With a Confirmed Tumor Response (Partial Response [PR] or Complete Response [CR] at Least 4 Weeks Apart)
时间窗: 1 year 4 months
The outcome measure is the number of participants with a confirmed tumor response (partial response \[PR\] or complete response \[CR\] at least 4 weeks apart). PR and CR are defined using RECIST 1.1 criteria. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target and non-target lesions and normalisation of tumour marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm.
次要结局
- Overall Survival (OS)(1 year 4 months)
- Progression-free Survival (PFS)(1 year 4 months)
- Number of Participants Experiencing at Least One Grade 3 or Worse Adverse Event (AE)(1 year 4 months)
- Number of Participants With a Confirmed Tumor Response (PR or CR at Least 4 Weeks Apart) in the Subset of Participants That Have Over-expression of Protein Kinase C (PKC) Iota(1 year 4 months)