Phase Ⅱ Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
18 Years
75 Years
Both
Small Cell Carcinoma of Lung
Trial Information
Phase Ⅱ Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
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.
Inclusion Criteria:
- Clinical diagnosis of refractory or relapsed small cell lung cancer
- Physical examination and routine laboratory tests show no contraindications to
chemotherapy
Exclusion Criteria:
- Pregnant and nursing women
- Brain metastasis with symptoms
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Side effect of chemotherapy
Outcome Description:
myelosuppression,diarrhea
Outcome Time Frame:
within the first 30 days (plus or minus 3 days) after chemotherapy
Safety Issue:
Yes
Principal Investigator
Fan Yun
Investigator Role:
Study Chair
Investigator Affiliation:
Zhejiang Cancer Hospital
Authority:
China: Ministry of Health
Study ID:
UGT1A1-01
NCT ID:
NCT01635400
Start Date:
June 2012
Completion Date:
June 2014
Related Keywords:
- Small Cell Carcinoma of Lung
- Irinotecan
- UGT1A1 Gene Polymorphisms
- Small Cell Carcinoma of Lung
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Small Cell
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