Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 49
- 主要终点
- Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of irinotecan administered with cisplatin and thoracic radiotherapy (given at two different schedules) in patients with limited stage small cell lung cancer.
- Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of these regimens in these patients.
- Determine the reversibility of all toxic effects associated with these regimens in these patients.
OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups.
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Radiotherapy:
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Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks.
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Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks.
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Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II.
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Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Sequence A: Level 1
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: cisplatin (Drug)
Sequence A: Level 1
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: irinotecan hydrochloride (Drug)
Sequence A: Level 1
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: radiation therapy (Radiation)
Sequence B: Level 1
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: cisplatin (Drug)
Sequence B: Level 1
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: irinotecan hydrochloride (Drug)
Sequence B: Level 1
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: radiation therapy (Radiation)
Sequence A: Level 2
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: cisplatin (Drug)
Sequence A: Level 2
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: irinotecan hydrochloride (Drug)
Sequence A: Level 2
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: radiation therapy (Radiation)
Sequence B: Level 2
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: cisplatin (Drug)
Sequence B: Level 2
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: irinotecan hydrochloride (Drug)
Sequence B: Level 2
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: radiation therapy (Radiation)
Sequence A: Level 3
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: cisplatin (Drug)
Sequence A: Level 3
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: irinotecan hydrochloride (Drug)
Sequence A: Level 3
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
干预措施: radiation therapy (Radiation)
Sequence B: Level 3
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: cisplatin (Drug)
Sequence B: Level 3
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: irinotecan hydrochloride (Drug)
Sequence B: Level 3
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity
时间窗: From the start of treatment until 90 days
次要结局
- Rate of non-dose limiting toxicity(From start of treatment to the end of follow-up)