Back to resultsStudy of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
Primary Purpose
Small Cell Carcinoma of Lung
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Irinotecan
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Carcinoma of Lung focused on measuring Irinotecan, UGT1A1 Gene Polymorphisms, Small Cell Carcinoma of Lung
Eligibility Criteria
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
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
UGT1A1 wild type (6/6)
UGT1A1 heterozygous genotype (6/7)
UGT1A1 homozygous genotype(7/7)
Arm Description
Outcomes
Primary Outcome Measures
Side effect of chemotherapy
myelosuppression,diarrhea
Secondary Outcome Measures
response rate of chemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01635400
Brief Title
Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
Official Title
Phase Ⅱ Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Carcinoma of Lung
Keywords
Irinotecan, UGT1A1 Gene Polymorphisms, Small Cell Carcinoma of Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UGT1A1 wild type (6/6)
Arm Type
Other
Arm Title
UGT1A1 heterozygous genotype (6/7)
Arm Type
Other
Arm Title
UGT1A1 homozygous genotype(7/7)
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
irinotecan 180mg/m2 i.v. over 30 min d1,q2w
Primary Outcome Measure Information:
Title
Side effect of chemotherapy
Description
myelosuppression,diarrhea
Time Frame
within the first 30 days (plus or minus 3 days) after chemotherapy
Secondary Outcome Measure Information:
Title
response rate of chemotherapy
Time Frame
tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fan Yun
Phone
86057188122192
Email
fanyun@csco.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan Yun
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan Yun
Phone
0086-571-88122192
Email
fanyun@csco.org.cn
First Name & Middle Initial & Last Name & Degree
Fan Yun
12. IPD Sharing Statement
Learn more about this trial
Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer
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