NCT00082212终止2 期
A Phase II Trial of Single-agent Cetuximab Dose Escalated to Rash in Patients With Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to determine the overall response rate, time to progression, and 1 yr survival with cetuximab in patients with ovarian or primary peritoneal carcinoma.
详细描述
To determine the overall response rate of cetuximab alone in subjects with ovarian or primary peritoneal carcinoma who have persistent or recurrent disease following 1-2 previous regimens of chemotherapy. Potential relationship between response, dose, and the occurence of rash in the treatment of subjects who have stable disease after the initial 6 weeks of treatment, time to progression, and 1 yr survival.
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
- •subjects must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma. Histologic confirmation of the original primary tumor is required.
- •EGFR expression must be positive as determined by an outside reference lab
- •Subjects must have had a treatment-free interval following platinum of <12 mos
- •All subjects must have measurable disease at baseline
- •Subjects must have at least one recurrent lesion to be used to assess response
- •Recovery from effect of recent surgery, radiotherapy or chemotherapy
排除标准
- •Subjects with other invasive malignancies (including peritoneal mesotheliomas)
- •Subjects with unstable cardiac disease or MI within 6 mos
- •Subjects with Acute hepatitis
- •Subjects with active or uncontrolled infection
- •A history of prior cetuximab or other therapy which targets the EGFR pathway or prior history of prior chimerized or murine monoclonal antibody therapy
结局指标
主要结局
Overall response rate
时间窗: Every six weeks
次要结局
- Relationship between response, dose, and occurence of rash(Every six weeks)
研究者
研究点 (6)
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