Phase II Trial of Imatinib Mesylate Maintenance Therapy in Patients With C-Kit (+) Extensive-Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving imatinib mesylate after irinotecan and cisplatin may keep the tumor from coming back.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate after irinotecan and cisplatin works in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the 4-month progression-free survival rate in patients with c-kit positive, extensive stage small cell lung cancer treated with maintenance therapy comprising imatinib mesylate after induction therapy comprising irinotecan and cisplatin.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the tolerability of imatinib mesylate maintenance therapy in these patients.
- Determine the response rate in patients treated with irinotecan and cisplatin.
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
Irinotecan, Cisplatin & Gleevec™
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease.
Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
干预措施: Cisplatin (Drug)
Irinotecan, Cisplatin & Gleevec™
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease.
Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
干预措施: Gleevec™ (Drug)
Irinotecan, Cisplatin & Gleevec™
Cisplatin 60mg/m2 IV day 1 every 21 days x 4 cycles
Gleevec™ 400 mg po BID (800mg/day)- for patients with objective response or stable disease.
Irinotecan 65 mg/m2 IV days 1, 8 every 21 days x 4 cycles
干预措施: irinotecan (Drug)
结局指标
主要结局
Progression-free survival
时间窗: at 4 months
次要结局
- Overall survival(at least 4 months after discontinuation of treatment)
- Tolerability of Gleevec maintenance therapy(30 days after completion of study treatment)
- Response rate as measured by RECIST at(Baseline and every 8 weeks during study treatment)