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

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT01635400
Phase
PHASE2
Status
Unknown

Conditions

  • Small Cell Carcinoma of Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2012
Status verified
Jun 2012
Primary completion
Jun 30, 2014
Completion
Jun 30, 2014

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: UGT1A1 wild type (6/6)
  • Other: UGT1A1 heterozygous genotype (6/7)
  • Other: UGT1A1 homozygous genotype(7/7)

Primary Outcome Measure

Side effect of chemotherapy [ Time Frame: within the first 30 days (plus or minus 3 days) after chemotherapy ]

Central Contacts

Related Studies