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

Small Cell Carcinoma of Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01635400
• Other study ID #: UGT1A1-01
• Status: Recruiting
• Phase: Phase 2
• First received: June 27, 2012
• Last updated: July 6, 2012
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2012
• Source: Zhejiang Cancer Hospital
• Contact: Fan Yun
• Phone: 86057188122192
• Email: fanyun[@]csco.org.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Lung Neoplasms
• Small Cell Carcinoma of Lung
• Small Cell Lung Carcinoma

Intervention

Drug:
• Irinotecan
irinotecan 180mg/m2 i.v. over 30 min d1,q2w

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effect of chemotherapy	myelosuppression,diarrhea	within the first 30 days (plus or minus 3 days) after chemotherapy	Yes
Secondary	response rate of chemotherapy		tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks	No