NCT00312650终止2 期
A Phase II Study of Every 2 Week Doxil and Gemcitabine in Recurrent Ovarian Cancer
Women and Infants Hospital of Rhode Island2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- rate of hand-foot syndrome
研究概览
简要总结
Standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. One of these drugs, Doxil, can cause skin toxicity at the standard dosages. This study investigates using a lower dose given more frequently in combination with a second drug Gemcitabine.
详细描述
This study will evaluate the toxicities of Doxil and Gemcitabine given on an every two week basis. Our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. Patients will also be evaluated with CT scans every 3 months. Toxicity will be assessed with every cycle of treatment. Treatment will continue until toxicity or signs of progression.
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
- •recurrent platinum resistant ovarian cancer
- •measurable disease
排除标准
- •prior treatment with Doxil or Gemzar
- •life expectancy <3months
- •cardiac ejection fraction <50%
结局指标
主要结局
rate of hand-foot syndrome
次要结局
- objective response rate
研究者
研究点 (2)
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