Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Radiographic Improvement
研究概览
简要总结
This study will evaluate the safety and efficacy of intraperitoneal administration of Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.
详细描述
This protocol describes a pilot study to assess whether intraperitoneal Bevacizumab infusion is safe and improves the time to repeat paracentesis. In patients with non-draining malignant peritoneal effusion, published data suggests that the average time to repeat paracentesis in malignant ascites is 10-13 Days. The investigators' treatment will be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included in the case of:
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
- •Participants must be 18 years of age or older
- •Have ascites of malignant disease
- •Have symptoms related to ascites
- •Ascites Index above 0.05 (AI ˃ 0.05)
- •Be an English speaking patient or have an interpreter available
- •Be able to understand and comply with all study requirements and the implications of off-label use of intraperitoneal Bevacizumab
- •Have had at least two paracentesis within the last 4 weeks
排除标准
- •Patients will be excluded in the case of:
- •Ascites due to non-malignant cause
- •Concurrent treatment with systemic chemotherapy that has a realistic chance of controlling the ascites
- •Concurrent treatment with intraperitoneal Bevacizumab
- •life expectancy of less than 2 weeks
- •A history of bowel perforation or fistula
- •Symptoms or signs suggestive of bacterial peritonitis
- •Child's C cirrhosis
- •Uncontrolled hypertension
- •Surgery within 28 days of catheter treatment
- •Evidence of coagulopathy
- •Symptoms suggestive of bowel obstruction
- •Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery.
- •Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.
- •Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
- •Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test prior to participation)
- •Patients with pre-existing 3 + or greater urine dipstick reading proteinuria
研究组 & 干预措施
Eligible patients requiring paracentesis for symptom control
干预措施: Intraperitoneal Bevacizumab (Drug)
结局指标
主要结局
Radiographic Improvement
时间窗: 14 days (+/-4 days)
Radiographic improvement in area of intraperitoneal collection will be evaluated (between the area of the intraperitoneal collection on the ultrasound pre-procedure and ultrasound evaluation on day 14 (+/-4 days).
Volume Output
时间窗: 14 days (+/-4 days)
Change in volume output from baseline to day 14 (+/-4 days)
次要结局
- Adverse Events(14 days (+/-4 days))