Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Small Cell Carcinoma of Lung

Treatments: Drug: Irinotecan

Study type: Interventional

Funder types: Other

Identifiers

NCT01635400

UGT1A1-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

UGT1A1 wild type (6/6)

Other group

Treatment:

Drug: Irinotecan

UGT1A1 heterozygous genotype (6/7)

Other group

Treatment:

Drug: Irinotecan

UGT1A1 homozygous genotype(7/7)

Other group

Treatment:

Drug: Irinotecan