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

July 6, 2012 updated by: Zhejiang Cancer Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Fan Yun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: UGT1A1 wild type (6/6)
Drug: Irinotecan
irinotecan 180mg/m2 i.v. over 30 min d1,q2w
Other: UGT1A1 heterozygous genotype (6/7)
Drug: Irinotecan
irinotecan 180mg/m2 i.v. over 30 min d1,q2w
Other: UGT1A1 homozygous genotype(7/7)
Drug: Irinotecan
irinotecan 180mg/m2 i.v. over 30 min d1,q2w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect of chemotherapy
Time Frame: within the first 30 days (plus or minus 3 days) after chemotherapy
myelosuppression,diarrhea
within the first 30 days (plus or minus 3 days) after chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate of chemotherapy
Time Frame: tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks
tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Study Chair: Fan Yun, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

July 6, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Estimate)

July 9, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGT1A1-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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