NCT00003092已完成3 期
Clinical Pharmacology of Paclitaxel in Relation to Patient Age
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 32
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase III trial to study the effectiveness of paclitaxel in treating older patients who have solid tumors.
详细描述
OBJECTIVES:
- Determine whether there is a relationship between pharmacokinetic measurements of paclitaxel and aging.
- Determine whether there is a relationship between the toxic effects of paclitaxel and aging.
OUTLINE: Patients are stratified according to age (cohort 1: patients 55 to 64 vs cohort 2: patients 65 to 75 vs cohort 3: patients 75 and over).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Paclitaxel
Experimental
Patients receive a single dose of IV paclitaxel over 3 hours. Additional cycles of paclitaxel will be given at the discretion of the physician.
Patients are followed for second malignancies, disease progression, and survival.
干预措施: paclitaxel (Drug)
结局指标
主要结局
Overall survival
时间窗: Up to 5 years
Disease-free progression
时间窗: Up to 5 years
次要结局
未报告次要终点
研究者
研究点 (32)
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