Phase II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib.
Secondary
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Celecoxib & ZD1839
Celecoxib: 400mg orally two times a day, taken with meals.
ZD1839: 250 mg po every day, taken with or without food.
干预措施: Celecoxib (Drug)
Celecoxib & ZD1839
Celecoxib: 400mg orally two times a day, taken with meals.
ZD1839: 250 mg po every day, taken with or without food.
干预措施: ZD1839 (Drug)
结局指标
主要结局
Response rate
时间窗: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation
CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.
次要结局
- Progression-free survival (PFS)(Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation)
- Overall survival(Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation)
- Toxicity of this drug combination(Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity)