A Pilot Study of Intravenous and Intraperitoneal Chemotherapy Plus Abdominal Hyperthermia to Treat Optimally Debulked and Recurrent Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Toxicity
研究概览
简要总结
This is a pilot study aimed to test the feasibility and safety of administering combination chemotherapy with paclitaxel (both intravenously and intraperitoneally) and cisplatin (intraperitoneally) plus whole abdominal hyperthermia every 3 weeks in the treatment of optimally debulked, advanced or recurrent ovarian, primary peritoneal, and fallopian tube cancer patients.
详细描述
Day 1 of each 21 day Cycle:
Paclitaxel 175 mg/m2 IV (infused over 3 hours)
Day 1 or 2 of each Cycle Adequate IV hydration with normal saline (1000 ml recommended)followed by intraperitoneal infusion of 500 ml normal saline through the IP port.
Cisplatin 75 mg/m2 reconstituted in 500 ml NS warmed to 37 degrees Celsius is infused IP (30 minute infusion)followed immediately by whole abdominal hyperthermia
Abdominal hyperthermia will be delivered using the BSD 2000 ellipse system to target temperatures of 40-42 degrees Celsius monitored via rectally and vaginally continuing for no greater than 60 minutes after maximal 30 minute warm-up phase. Total duration of hyperthermia will be no greater than 90 minutes.
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 72 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed Stage III or Stage IV advanced, persistent, or recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
- •Optimal debulking (< 1cm residual disease) of their disease within 6 weeks of the start of the study
- •Patients must have received no more than 2 prior chemotherapy regimens with at least 4 weeks since prior chemotherapy
- •GOG performance status 0, 1, or 2
- •Patients must have normal organ and marrow function defined as:
- •absolute neutrophil count >1,500/mcL
- •platelets >100,000/mcL
- •total bilirubin and creatinine <1.5 X institutional upper limit of normal(ULN)
- •AST(SGOT)/ALT(SGPT)<3 X institutional ULN
排除标准
- •Patients with biochemical recurrences or evidence of measurable disease
- •Patients with suboptimal (>1 cm) residual disease
- •Patients who have had chemotherapy within 4 weeks prior
- •Receiving any investigational agents
- •Known brain metastases
- •Epithelial ovarian carcinoma of low malignant potential (borderline carcinomas)
- •Uncontrolled intercurrent illness
- •Prior radiation therapy
- •History of other invasive or pre-invasive malignancies (except non-melanoma skin cancer) within the past 5 years
结局指标
主要结局
Toxicity
时间窗: 6 months
次要结局
- Clinically free of disease. Response definitions will be based on CA-125, clinical assessment, CT imaging(1 year)
研究者
Mark Dewhirst
Professor
Duke University