Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with extensive stage small cell lung cancer.
- Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients.
Secondary
- Determine progression-free survival, tumor response rate, and overall survival in patients treated with this regimen.
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
Oral cyclophosphamide plus standard cisplatin with etoposide
- Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3
- Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles
- Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
干预措施: cisplatin (Drug)
Oral cyclophosphamide plus standard cisplatin with etoposide
- Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3
- Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles
- Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
干预措施: cyclophosphamide (Drug)
Oral cyclophosphamide plus standard cisplatin with etoposide
- Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3
- Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles
- Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
干预措施: etoposide (Drug)
结局指标
主要结局
Safety
时间窗: From time of registration to 30 days post treatment of last cycle.
Effect of metronomic chemotherapy on circulating endothelial cells
时间窗: Baseline to progression
Collected cycle 1/day 1 of chemotherapy, Cycle 1/day 8, cycle 1/day 22, and then day 85 and 141, and at disease progression.
次要结局
- Progression-free survival(Registration to time of progression)
- Response rate(From Registration to time of disease progression)
- Overall survival(From registration to time patient expires)
研究者
Ronald Go
Hematologist
Gundersen Lutheran Health System