Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
- Registration Number
- NCT01635400
- Lead Sponsor
- Zhejiang Cancer Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Clinical diagnosis of refractory or relapsed small cell lung cancer
- Physical examination and routine laboratory tests show no contraindications to chemotherapy
- Pregnant and nursing women
- Brain metastasis with symptoms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UGT1A1 homozygous genotype(7/7) Irinotecan - UGT1A1 wild type (6/6) Irinotecan - UGT1A1 heterozygous genotype (6/7) Irinotecan -
- Primary Outcome Measures
Name Time Method Side effect of chemotherapy within the first 30 days (plus or minus 3 days) after chemotherapy myelosuppression,diarrhea
- Secondary Outcome Measures
Name Time Method response rate of chemotherapy tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks
Trial Locations
- Locations (1)
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China