NCT01635400

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 9, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

June 27, 2012

Last Update Submit

July 6, 2012

Conditions

Small Cell Carcinoma of Lung

Keywords

IrinotecanUGT1A1 Gene PolymorphismsSmall Cell Carcinoma of Lung

Outcome Measures

Primary Outcomes (1)

  • Side effect of chemotherapy

    myelosuppression,diarrhea

    within the first 30 days (plus or minus 3 days) after chemotherapy

Secondary Outcomes (1)

  • response rate of chemotherapy

    tumor assessments after two cycles of chemotherapy,an expected average of 6 weeks

Study Arms (3)

UGT1A1 wild type (6/6)

OTHER
Drug: Irinotecan

UGT1A1 heterozygous genotype (6/7)

OTHER
Drug: Irinotecan

UGT1A1 homozygous genotype(7/7)

OTHER
Drug: Irinotecan

Interventions

IrinotecanDRUG

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

UGT1A1 heterozygous genotype (6/7)UGT1A1 homozygous genotype(7/7)UGT1A1 wild type (6/6)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of refractory or relapsed small cell lung cancer
  • Physical examination and routine laboratory tests show no contraindications to chemotherapy

You may not qualify if:

  • Pregnant and nursing women
  • Brain metastasis with symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Fan Yun

    Zhejiang Cancer Hospital

    STUDY CHAIR

Central Study Contacts

Fan Yun

CONTACT

86057188122192fanyun@csco.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2012

First Posted

July 9, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 9, 2012

Record last verified: 2012-06

Locations

CN(1)