NCT00170677已完成2 期
Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Rate of CR and PR in each arm
研究概览
简要总结
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.
详细描述
Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 histologically-confirmed ovarian cancer
- •relapse within 6 month after primary therapy
- •primary therapy with platin and taxan
- •>= 18 years
- •leukocytes >= 3.000/ µl
- •platelet >= 100.000/ µl
- •neutrophil >= 1.500/ µl
- •written informed consent
排除标准
- •earlier topotecan therapy
- •simultaneous or planned radiotherapy
- •secondary malignancy
研究组 & 干预措施
A
Active Comparator
干预措施: Topotecan (Drug)
B
Experimental
干预措施: Topotecan (Drug)
结局指标
主要结局
Rate of CR and PR in each arm
时间窗: every 12 weeks
次要结局
- Toxicity of topotecan treatment(after each cycle)
- Progression-free survival of both arms(every 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung CancerLung Cancer, Non-Small CellNon-Small-Cell Lung CancerNCT00065182GlaxoSmithKline399
已完成
1 期
Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid TumorsCancerNCT00193583SCRI Development Innovations, LLC18
终止
2 期
Weekly Topotecan Therapy in Patients With Ovarian CancerOvarian CancerNCT00194935Weill Medical College of Cornell University32
已完成
2 期
Weekly Topotecan in Patients Treated for Metastatic Colorectal CancerColon CancerNCT00193167SCRI Development Innovations, LLC40
终止
1 期
Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical CancerCervix CancerNCT00322920University of Alabama at Birmingham30