Bevacizumab and tocotrienol in recurrent ovarian cancer. A marker based phase II trial

Vejle Hospital0 个研究点目标入组 60 人开始时间: 2019年5月10日最近更新: 2024年8月26日

适应症

试验速览

暂无简介。

•Histologically confirmed epithelial ovarian cancer, primary fallopian or primary peritoneal cancer.
•Platinum resistant epithelial ovarian cancer treated with at least two different previous chemotherapeutic regimens
•Progression on previous treatment. Previous treatment with bevacizumab is allowed.
•Measurable disease by the RECIST 1.1 criteria or evaluable by the GCIG CA-125 criteria.
•Age = 18 years.
•Performance status 0-2.
•Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
•oWBC = 3.0 x 10^9/l or neutrophils (ANC) = 1.5 x 10^9/l
•oPlatelet count = 100 x 10^9/l
•oHemoglobin = 6 mmol/l
•oSerum bilirubin < 2.0 x ULN
•oSerum transaminase = 2.5 x ULN
•oSerum creatinine = 1.5 ULN
•Urine dipstick for protein < 2+. If the dipstick shows protein = 2+, 24 hour urine testing must be performed and show protein contents < 1 g.
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Other malignant diseases within 3 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin.
•Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
•Intestinal infiltration or infiltration in major blood vessels at the discretion of the treating physician.
•Underlying medical disease not adequately treated (diabetes, cardiac disease).
•Uncontrolled hypertension (BP > 150/100 despite antihypertensive treatment).
•Surgery including open biopsy, within 4 weeks prior to first dose of bevacizumab.
•Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within 6 months before start of treatment.
•Clinical significant cardiovascular disease, including:
•oMyocardial infarction or unstable angina within 6 months before start of treatment
•oNew York Heart Association (NYHA) class = 2
•oPoorly controlled cardiac arrhythmia despite medication
•oPeripheral vascular disease grade = 3
•Allergy to active substance or any of the auxiliary agents
•Bleeding tumor
•Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
•Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.

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