NCT00049998已完成3 期
An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 760
- 试验地点
- 115
- 主要终点
- One-year survival rate
研究概览
简要总结
The purpose of this study is to collect information on how effective and how well tolerated an oral investigational drug is compared to a standard intravenous drug in patients with pretreated, advanced non-small lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Patients with advanced non-small cell lung cancer (NSCLC).
- •Patients who have received one previous chemotherapy for NSCLC.
- •Full recovery from previous chemotherapy.
- •Presence of either measurable or non-measurable disease by radiologic study or physical examination.
- •At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in the best interest of the patient).
- •At least 24 hours since prior radiotherapy providing that marked bone marrow suppression is NOT expected. Patients who have received radiotherapy must have recovered from any reversible side effects (e.g. nausea and vomiting).
- •Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
排除标准
- •Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment with steroids.
- •Active infection.
- •Severe medical problems other than the diagnosis of NSCLC, that would limit the ability of the patient to follow study guidelines or expose the patient to extreme risk.
- •Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.
- •Use of investigational drug within 30 days prior to the first dose of study medication.
- •Women who are pregnant or lactating.
- •Patients of child-bearing potential refusing to practice adequate birth control methods.
- •Patients with conditions which might alter absorption of an oral drug.
结局指标
主要结局
One-year survival rate
次要结局
- overall survival, time to progression, response rate, response duration, time to response, improvement in quality of life and patient well-being, and qualitative and quantitative toxicities.
研究者
研究点 (115)
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