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

NCT ID: NCT01635400

Last Updated: 2012-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Small Cell Carcinoma of Lung

Keywords

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Irinotecan UGT1A1 Gene Polymorphisms Small Cell Carcinoma of Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UGT1A1 wild type (6/6)

Group Type OTHER

Irinotecan

Intervention Type DRUG

irinotecan 180mg/m2 i.v. over 30 min d1,q2w

UGT1A1 heterozygous genotype (6/7)

Group Type OTHER

Irinotecan

Intervention Type DRUG

irinotecan 180mg/m2 i.v. over 30 min d1,q2w

UGT1A1 homozygous genotype(7/7)

Group Type OTHER

Irinotecan

Intervention Type DRUG

irinotecan 180mg/m2 i.v. over 30 min d1,q2w

Interventions

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Irinotecan

irinotecan 180mg/m2 i.v. over 30 min d1,q2w

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fan Yun

Role: STUDY_CHAIR

Zhejiang Cancer Hospital

Locations

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Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fan Yun

Role: CONTACT

Phone: 86057188122192

Email: [email protected]

Facility Contacts

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Fan Yun

Role: primary

Other Identifiers

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UGT1A1-01

Identifier Type: -

Identifier Source: org_study_id