A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 87
- 主要终点
- Feasibility and 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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer.
- Determine the toxicities of this treatment regimen in these patients.
- Determine the response rate in these patients treated with this regimen.
OUTLINE: Patients are assigned to one of two induction therapy arms.
- Arm I: Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1.
- Arm II: Patients receive induction chemotherapy consisting of high-dose tirapazamine, cisplatin, etoposide, and radiotherapy as in arm I.
Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.
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
chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
干预措施: cisplatin (Drug)
chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
干预措施: etoposide (Drug)
chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
干预措施: tirapazamine (Drug)
chemo/RT with tirapazamine
induction and consolidation: cisplatin, etoposide, tirapazamine, radiation therapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Feasibility and Toxicity
时间窗: toxicity is assessed weekly
If ten or more patients experience either Grade 3 or greater esophagitis or pneumonitis at any dose level, the trial will be stopped. Nine or fewer patients experiencing either of these toxicities will be evidence that the dose can be escalated to the next level.
次要结局
未报告次要终点