Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
研究概览
简要总结
The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.
A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.
Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •≥ 18 years old
- •ECOG score of 0, 1, or 2
- •Histologically confirmed diagnosis of non-small cell lung cancer
排除标准
- •Laboratory values demonstrating inadequate function of the following:
- •Bone marrow
- •Peripheral neuropathy Grade 2 or higher
- •Greater than 2 prior chemotherapy regimens
结局指标
主要结局
Dose limiting toxicities of MGd when administered concurrently with docetaxel and cisplatin
Maximum tolerated dose of MGd when administered concurrently with docetaxel and cisplatin
次要结局
- Tumor response