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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Zhejiang Cancer Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01635400
First received: June 27, 2012
Last updated: July 6, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Small Cell Carcinoma of Lung
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Relationship Between UGT1A1 Gene Polymorphism and Toxicity and Efficacy of Irinotecan in Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Zhejiang Cancer Hospital:

Primary Outcome Measures:
  • Side effect of chemotherapy [ Time Frame: within the first 30 days (plus or minus 3 days) after chemotherapy ] [ Designated as safety issue: Yes ]
    myelosuppression,diarrhea


Secondary Outcome Measures:
  • response rate of chemotherapy [ Time Frame: tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
UGT1A1 wild type (6/6) Drug: Irinotecan
irinotecan 180mg/m2 i.v. over 30 min d1,q2w
Other Name: Irinotecan
UGT1A1 heterozygous genotype (6/7) Drug: Irinotecan
irinotecan 180mg/m2 i.v. over 30 min d1,q2w
Other Name: Irinotecan
UGT1A1 homozygous genotype(7/7) Drug: Irinotecan
irinotecan 180mg/m2 i.v. over 30 min d1,q2w
Other Name: Irinotecan

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635400

Contacts
Contact: Fan Yun 86057188122192 fanyun@csco.org.cn

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Fan Yun    0086-571-88122192    fanyun@csco.org.cn   
Principal Investigator: Fan Yun         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Study Chair: Fan Yun Zhejiang Cancer Hospital
  More Information

No publications provided

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT01635400     History of Changes
Other Study ID Numbers: UGT1A1-01
Study First Received: June 27, 2012
Last Updated: July 6, 2012
Health Authority: China: Ministry of Health

Keywords provided by Zhejiang Cancer Hospital:
Irinotecan
UGT1A1 Gene Polymorphisms
Small Cell Carcinoma of Lung

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014