Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, 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.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin.
- Determine the median survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).
Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
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
Metastatic SCLC
Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles
干预措施: carboplatin (Drug)
Metastatic SCLC
Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles
干预措施: irinotecan (Drug)
Relapsed SCLC
Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles
干预措施: carboplatin (Drug)
Relapsed SCLC
Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles
干预措施: irinotecan (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: Up to 36 months
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Median Survival of Patients Treated With This Regimen(Up to 36 months)
- Number of Participants With Toxicity(Up to 36 months)