NCT00201812已完成1 期
Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept.
研究概览
简要总结
To determine the safety and efficacy of the combination of Etanercept and Docetaxel in patients with advanced solid tumors for which there is no standard treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have pathologically or cytologically confirmed advanced solid malignancy for which there is no standard treatment exists.
- •Solid malignancy that has persisted or recurred following prior therapy or advanced solid malignancy for which docetaxel is considered an acceptable first line treatment option:
- •Non-Small Cell Lung
- •Head and Neck
- •Esophageal
- •Ovarian carcinomas
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •Life expectancy of at least 12 weeks.
- •Must have adequate organ function
- •Peripheral Neuropathy must be less than Grade 2
排除标准
- 未提供
结局指标
主要结局
Determine maximum tolerated dose (MTD) of weekly docetaxel in combination with etanercept.
时间窗: up to 4 years
次要结局
- Characterize toxicities of weekly docetaxel when administered weekly to patients with solid malignancies to determine if co-administration of etanercept can result in higher tolerated doses of docetaxel.(up to 4 years)
- Determine if weekly docetaxel administration is associated with increased expression of TNF and if inactivation of TNF by etanercept is associated with a decrease in the rate of moderate to severe asthenia.(up to 4 years)
- Preliminarily evaluate antitumor activity for docetaxel in combination with etanercept.(up to 4 years)
研究者
研究点 (2)
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