Randomized Phase II Study of Eicosanoid Pathway Modulators and Cytotoxic Chemotherapy in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 75
- 主要终点
- Disease free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton may stop the growth of tumor cells by stopping blood flow to the tumor and may block the enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or zileuton may kill more tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Compare the efficacy of carboplatin and gemcitabine with celecoxib and/or zileuton, in terms of 7-month progression-free survival, in patients with advanced non-small cell lung cancer.
Secondary
- Compare the response rate, distribution of survival, and failure-free survival time of patients treated with these regimens.
- Correlate CYFRA and serum vascular endothelial growth factor levels with response and survival of patients treated with these regimens.
- Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Gem + Carboplatin + Zileuton
干预措施: zileuton (Drug)
Gem + Carboplatin + Zileuton
干预措施: carboplatin (Drug)
Gem + Carboplatin + Zileuton
干预措施: gemcitabine hydrochloride (Drug)
Gem + Carboplatin + celecoxib
干预措施: carboplatin (Drug)
Gem + Carboplatin + celecoxib
干预措施: celecoxib (Drug)
Gem + Carboplatin + celecoxib
干预措施: gemcitabine hydrochloride (Drug)
Gem + carboplatin + zilueton + celecoxib
干预措施: carboplatin (Drug)
Gem + carboplatin + zilueton + celecoxib
干预措施: celecoxib (Drug)
Gem + carboplatin + zilueton + celecoxib
干预措施: gemcitabine hydrochloride (Drug)
Gem + carboplatin + zilueton + celecoxib
干预措施: zileuton (Drug)
结局指标
主要结局
Disease free survival
时间窗: 9 months
次要结局
未报告次要终点