A Phase II Trial of Intraperitoneal Paclitaxel and Carboplatin Therapy in the Treatment of Women With Newly Diagnosed, Optimally Cytoreduced Carcinoma of Mullerian Origin
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
研究概览
简要总结
The main purpose of this study is to determine the safety and tolerability of giving both paclitaxel and carboplatin in the abdominal cavity by looking at what effects (good and bad) this route of administration has on patients with ovarian cancer. Standard chemotherapy drugs are administered intravenously but a number of trials have shown that injecting drugs into the abdominal cavity, or intraperitoneally, have shown promising results.
详细描述
Patients will have an intraperitoneal port placed at the time of their initial surgery or at a second procedure prior to cycle 2 of chemotherapy.
Patients will receive a total of 6 cycles of therapy as an outpatient. They will have 1 cycle of paclitaxel/carboplatin intravenously followed by 5 cycles of paclitaxel/carboplatin intraperitoneally. Chemotherapy treatment is given on days 1, 8, and 15 of each cycle. Each cycle is 21 days long.
To help reduce the chance of an allergic reaction, patients will also take decadron tablets orally before paclitaxel administration.
About 1 liter of standard salt solution will be injected through a catheter into the abdominal cavity with each treatment to help distribute the drugs throughout the abdominal cavity.
"Second-look" surgery (laparoscopy or laparotomy) will be performed 3-8 weeks after the last chemotherapy course (cycle 6) if the patient is in complete clinical remission. This surgery is done to see how effective the chemotherapy was.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 carcinoma of mullerian origin. Specifically, ovarian, primary peritoneal and tubal carcinoma
- •Stage II or III disease
- •Patient must have undergone surgical staging and debulking with optimal cytoreduction
- •Able and willing to undergo a second look staging laparotomy
- •18 years of age or older
- •Adequate bone marrow function with an Absolute Neutrophil Count (ANC) > 2,500 and platelets > 100,000/mm3
- •ECOG performance status less than or equal to 2
排除标准
- •Disease outside the abdominal cavity
- •Stage IV disease, including abdominal wall, visceral and/or pleural involvement
- •Previous chemotherapy for ovarian cancer
- •Suboptimal cytoreduction
- •Creatinine > 1.5 mg/dl
- •History of recent Myocardial Infarction or congestive heart failure within 6 months of surgery
- •SGOT > 2x Upper Limit of Normal (ULN), bilirubin > 1.5 x ULN
- •Colostomy or ileostomy
- •Concurrent invasive malignancy
- •Known hypersensitivity to E. coli derived products
- •Active psychiatric or mental illness precluding informed consent
结局指标
主要结局
To investigate the safety and tolerability of carboplatin and paclitaxel administered intraperitoneally
次要结局
- To determine the efficacy of this regimen as defined by surgical response rate
研究者
Richard Thomas Penson
Clinical Director Medical Gynecologic Oncology
Massachusetts General Hospital