NCT02399592已完成2 期
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Fraction of patients without progression after six months of treatment
研究概览
简要总结
The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.
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
- •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-
- •Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- •WBC ≥ 3.0 * 10^9/l or neutrophils (ANC) ≥ 1.5 * 109/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.
排除标准
- •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
研究组 & 干预措施
Bevacizumab and Tocotrienol
Experimental
干预措施: Bevacizumab (Drug)
Bevacizumab and Tocotrienol
Experimental
干预措施: Tocotrinol (Drug)
结局指标
主要结局
Fraction of patients without progression after six months of treatment
时间窗: 6 months after start of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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