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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01635400
Enrollment
50
Registered
2012-07-09
Start date
2012-06-30
Completion date
2014-06-30
Last updated
2012-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Carcinoma of Lung

Keywords

Irinotecan, UGT1A1 Gene Polymorphisms, Small Cell Carcinoma of Lung

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.

Interventions

DRUGIrinotecan

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

Sponsors

Zhejiang Cancer Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Side effect of chemotherapywithin the first 30 days (plus or minus 3 days) after chemotherapymyelosuppression,diarrhea

Secondary

MeasureTime frame
response rate of chemotherapytumor assessments after two cycles of chemotherapy,an expected average of 6 weeks

Countries

China

Contacts

Primary ContactFan Yun
fanyun@csco.org.cn86057188122192

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026