Phase Ⅱ Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Side effect of chemotherapy
研究概览
简要总结
The purpose of this study is to find out the correlation between uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer.
详细描述
In multiple studies of metastatic colorectal cancer,uridine diphosphate glucuronosyl transferase 1A1(UGT1A1) gene polymorphisms and its correlation with irinotecan-associated side effects have been confirmed.Data from several studies indicated an improved clinical outcome of patients who had received an irinotecan-based regimen.In order to find out the correlation between UGT1A1 gene polymorphisms and the side effect and efficacy of irinotecan in patients with small cell lung cancer,we designed this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of refractory or relapsed small cell lung cancer
- •Physical examination and routine laboratory tests show no contraindications to chemotherapy
排除标准
- •Pregnant and nursing women
- •Brain metastasis with symptoms
研究组 & 干预措施
UGT1A1 wild type (6/6)
干预措施: Irinotecan (Drug)
UGT1A1 heterozygous genotype (6/7)
干预措施: Irinotecan (Drug)
UGT1A1 homozygous genotype(7/7)
干预措施: Irinotecan (Drug)
结局指标
主要结局
Side effect of chemotherapy
时间窗: within the first 30 days (plus or minus 3 days) after chemotherapy
myelosuppression,diarrhea
次要结局
- response rate of chemotherapy(tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks)