Tocotrienol as a nutritional supplement in patients with advanced ovarian cancer

Vejle Hospital0 个研究点目标入组 23 人开始时间: 2014年12月19日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
•Prior treatment with at least two different cytostatic regimens including platinum.
•Progression on previous treatment.
•Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.
•Age = 18 years.
•Performance stage 0-2.
•Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
•- WBC = 3.0 * 109/l or neutrophils (ANC) = 1.5 * 10^9/l
•- Platelet count = 100 * 10^9/l
•- Hemoglobin = 6 mmol/l
•- Serum bilirubin < 2.0 * ULN
•- Serum transaminase = 2.5 * ULN
•- Serum creatinine = 1.5 ULN
•Urine dipstick for protein <2+. If the dipstick shows protein =2+ 24 hour urine testing must be made with 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 13
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.
•Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
•Underlying medical disease not adequately treated (diabetes, cardiac disease).
•Uncontrolled hypertension (BT >150/100 despite antihypertensive treatment).
•Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.
•Non-healing wounds or fractures.
•Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.
•Clinically significant cardiovascular disease, including:
•-Myocardial infarction or unstable angina within 6 months before start of treatment
•-New York heart Association (NYHA) class = 2
•-Poorly controlled cardiac arrhythmia despite medication
•-Periferal vascular disease grade = 3
•Allergy to the 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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