NCT00193297已完成2 期
A Phase II Study of a Three-Day Schedule of Topotecan Plus Paclitaxel and Carboplatin on Day Three in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and toxicity of the combination of paclitaxel, carboplatin, and topotecan in patients with previously untreated, stage III or IV epithelial ovarian carcinoma or primary peritoneal carcinoma. We will also make a preliminary evaluation of the efficacy of this three drug regimen in the initial treatment of these patients.
详细描述
Upon determination of eligibility, all patients will be receive:
Paclitaxel + Carboplatin + Topotecan
a maximum of six courses of chemotherapy will be given at 21 day intervals
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
- •To be included in this study, you must meet the following criteria:
- •Epithelial ovarian carcinoma or primary peritoneal carcinoma
- •Willing to consider second-look surgery to evaluate response if necessary
- •No previous treatment with chemotherapy or radiation therapy
- •Ability to perform activities of daily living with minimal assistance
- •Adequate bone marrow, liver and kidney function
- •Written informed consent
排除标准
- •You cannot participate in this study if any of the following apply to you:
- •Age < 18 years
- •Brain metastases
- •Recent history of significant heart disease within 6 months
- •Other significant medical conditions
- •Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
结局指标
主要结局
Overall response rate
次要结局
- Overall toxicity
研究者
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