NCT00330044已完成1 期
A Phase I Study of Premetrexed (Alimta) and Carboplatin and Radiation Therapy in Patients With Inoperable Non Small Cell Lung Cancer.
Sidney Kimmel Cancer Center at Thomas Jefferson University1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2006年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Response and Progression Free Survival
研究概览
简要总结
To determine the safety of Alimta when used with chemoradiation in inoperable non small cell lung cancer
详细描述
To determine the maximal tolerated dose (MTD) and toxicities of Pemetrexed (Alimta) when administered concurrently with carboplatin and thoracic radiation therapy.
To determine, qualitatively, the occurrence of local tumor responses identified with this regimen.
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
- •Unresectable Stage II, IIIB or IV non small cell lung cancer. Evaluable disease on planning CT scan Zubrod 0-1 Weight loss equal to or less than 10% 3 months prior to diagnosis FEV1 greater than 1000cc Adequate hematologic, renal and hepatic functions
排除标准
- •Small cell cancer Stage I non small cell cancer Prior chemotherapy or thoracic or lower neck radiatio therapy
研究组 & 干预措施
Drug
Experimental
Carboplatin and Pemetrexed
干预措施: Premetrexed (Alimta) (Drug)
Drug
Experimental
Carboplatin and Pemetrexed
干预措施: Carboplatin (Drug)
结局指标
主要结局
Response and Progression Free Survival
时间窗: Up to five years after study completion
次要结局
未报告次要终点
研究者
研究点 (1)
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