Bevacizumab and Tocotrienol in Recurrent Ovarian Cancer: A Marker Based Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
A recent study at the Department of Oncology, Vejle Hospital (NCT02399592), investigated bevacizumab and tocotrienol in ovarian cancer patients and concurrently monitored the level of methylated HOXA9 circulating tumor DNA (HOXA9 meth-ctDNA) in the blood.
The rate of disease control was 70% with better results than other studies using bevacizumab alone. The toxicity was very low and attributed to bevacizumab only.
When the study results were worked up they showed that patients with a significant increase of HOXA9 meth-ctDNA after the first cycle of treatment did not benefit from the treatment whereas those with stable or decreasing HOXA9 meth-ctDNA did.
Therefore, in the current study patients with a high increase of HOXA9 meth-ctDNA after the first treatment cycle will discontinue treatment, as it is then considered ineffective. The remaining patients may achieve prolonged survival as predicted by their level of HOXA9 meth-ctDNA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 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-
- •Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- •WBC ≥ 3.0 x 10^9/l or neutrophils (ANC) ≥ 1.5 x 10^9/l
- •Platelet count ≥ 100 x 10^9/l
- •Hemoglobin ≥ 6 mmol/l
- •Serum bilirubin < 2.0 x ULN
- •Serum transaminase ≤ 2.5 x ULN
- •Serum 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
排除标准
- •Other malignant disease 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:
- •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
- •Peripheral 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.
研究组 & 干预措施
Arm B: Continue treatment until progression
干预措施: Bevacizumab (Drug)
Arm B: Continue treatment until progression
干预措施: Tocotrienol (Dietary Supplement)
Arm A: Discontinue treatment after first treatment cycle
干预措施: Bevacizumab (Drug)
Arm A: Discontinue treatment after first treatment cycle
干预措施: Tocotrienol (Dietary Supplement)
结局指标
主要结局
Progression free survival
时间窗: 6 months after enrollment of the last patient
次要结局
- Overall survival(12 months after enrollment of the last patient)
- Response rate as measured by RECIST 1.1 or CA-125(6 months after enrollment of the last patient)
- Safety as measured by CTC version 5.0(Every 9 weeks until progression, up to 3 years)