A Phase I/II Trial of Protease Inhibitor, Nelfinavir, Given With Concurrent Thoracic Chemoradiotherapy in Patients With Locally-Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Dose-limiting Toxicity
研究概览
简要总结
RATIONALE: Nelfinavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Nelfinavir may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir together with radiation therapy, cisplatin, and etoposide may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of nelfinavir when given together with radiation therapy, cisplatin, and etoposide and to see how well they work in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the dose-limiting toxicities, maximum tolerated dose, and recommended phase II dose of nelfinavir mesylate when administered in combination with concurrent thoracic radiotherapy, cisplatin, and etoposide in patients with unresectable locally advanced non-small cell lung cancer.
Secondary
- To determine the tumor response at 3 months after completion of treatment as measured by RECIST criteria.
- To assess the inhibition of p-Akt in primary tumor or pathologic lymph nodes and in peripheral blood lymphocytes after 5-10 days of treatment with nelfinavir mesylate.
- To determine the median overall survival (OS) of patients treated with this regimen.
- To compare the observed median OS of these patients with the historical median OS of 17 months.
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 120 Years（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
Single arm
Nelfinavir
干预措施: cisplatin (Drug)
Single arm
Nelfinavir
干预措施: etoposide (Drug)
Single arm
Nelfinavir
干预措施: nelfinavir mesylate (Drug)
Single arm
Nelfinavir
干预措施: protein expression analysis (Genetic)
Single arm
Nelfinavir
干预措施: immunohistochemistry staining method (Other)
Single arm
Nelfinavir
干预措施: laboratory biomarker analysis (Other)
Single arm
Nelfinavir
干预措施: biopsy (Procedure)
Single arm
Nelfinavir
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Dose-limiting Toxicity
时间窗: 90 days
Any grade III or higher toxicity during chemoradiation, per CTCAE
Maximum Tolerated Dose of Nelfinavir
时间窗: 90 days
As determined by dose escalation rules
次要结局
- Clinical Response of Tumor(90 days)