Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer
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
- Number of Patients Able to Complete 6 Cycles of Treatment.
研究概览
简要总结
The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.
详细描述
Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.
Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.
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
- •Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
- •Adequate bone marrow, renal, and hepatic function
- •Patients must be entered no more than twelve weeks postoperatively
排除标准
- •Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
- •Stage IV or suboptimally debulked disease following primary cytoreductive surgery
- •Patients who have received prior radiotherapy or chemotherapy.
研究组 & 干预措施
Avastin
干预措施: Avastin (Drug)
Avastin
干预措施: Paclitaxel (Drug)
Avastin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Number of Patients Able to Complete 6 Cycles of Treatment.
时间窗: 2 years
Completion of cycle 6
次要结局
- Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.(2 years)