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Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients

Primary Purpose

Stage IV Colorectal Cancer, Gastric Cancer

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Irinotecan, 5FU, leucovorin
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Colorectal Cancer focused on measuring Colorecatal cancer, Gastric cancer, Irinotecan, UGT1A1, Neutropenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Subjects should meet all of the following criteria to participate in the trial.

  • Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy
  • Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment.
  • Aged 18 years or older.
  • ECOG performance status of ≤ 2.
  • Anticipated life expectancy of ≥ 3 months.

  • Clinically acceptable function of bone marrow, kidney and liver function as below.

    1. ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3
    2. Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
    3. Serum creatinine ≤ 1.5 mg/dL or CLcr > 60 ml/min
  • Subjects whose written informed consent can be obtained prior to their participation in the trial.

Exclusion Criteria: Subjects who meet any of the following criteria should not be included in the trial.

  • Pregnant or breast feeding women
  • Serious concurrent complication, severe active infection.
  • Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis
  • Subjects with epilepsia or severe psychiatric disorders.
  • Subjects who are regarded to be unsuitable for this trial by the investigator.
  • Subjects who are participating in other clinical trials
  • Subjects who have received prior chemotherapy including irinotecan.

Sites / Locations

  • Samsung Medical Center
  • Hwasun Hospital
  • Korea Cancer Center Hospital
  • Asan Medical Center
  • National Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOLFIRI

Arm Description

Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study)

Outcomes

Primary Outcome Measures

Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
During the first cycle of treatment

Secondary Outcome Measures

Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration
During all treatment period(during 12 cycle, each 2 weeks)
Association between grade 3/4 diarrhea and UGT1A1 polymorphism
During the first cycle of treatment
Progression-free survival
The time from registration to objective tumor progression or death

Full Information

First Posted
January 4, 2011
Last Updated
January 27, 2019
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01271582
Brief Title
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients
Official Title
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the association between UGT1A1 polymorphisms and neutropenia and diarrhea in Korean patients with advanced colorectal or gastric cancer treated with FOLFIRI regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Colorectal Cancer, Gastric Cancer
Keywords
Colorecatal cancer, Gastric cancer, Irinotecan, UGT1A1, Neutropenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOLFIRI
Arm Type
Experimental
Arm Description
Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study)
Intervention Type
Drug
Intervention Name(s)
Irinotecan, 5FU, leucovorin
Other Intervention Name(s)
CAMPTO (CAMPOSAR)
Intervention Description
FOLFIRI regimen every 2 weeks [irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)]
Primary Outcome Measure Information:
Title
Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment
Description
During the first cycle of treatment
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration
Description
During all treatment period(during 12 cycle, each 2 weeks)
Time Frame
24 weeks
Title
Association between grade 3/4 diarrhea and UGT1A1 polymorphism
Description
During the first cycle of treatment
Time Frame
2 weeks
Title
Progression-free survival
Description
The time from registration to objective tumor progression or death
Time Frame
6 months (average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Subjects should meet all of the following criteria to participate in the trial. Histologically confirmed colorectal or gastric cancer patients who are chemonaive or failed to 1st line chemotherapy Subjects who are expected to receive toxicity test at least once after FOLFIRI treatment. Aged 18 years or older. ECOG performance status of ≤ 2. Anticipated life expectancy of ≥ 3 months. Clinically acceptable function of bone marrow, kidney and liver function as below. ANC ≥ 1500/mm3 and platelet count ≥ 100,000/mm3 Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present) Serum creatinine ≤ 1.5 mg/dL or CLcr > 60 ml/min Subjects whose written informed consent can be obtained prior to their participation in the trial. Exclusion Criteria: Subjects who meet any of the following criteria should not be included in the trial. Pregnant or breast feeding women Serious concurrent complication, severe active infection. Subjects with chronic diarrhea, paralytic ileums, pulmonary fibrosis or pneumonia interstitialis Subjects with epilepsia or severe psychiatric disorders. Subjects who are regarded to be unsuitable for this trial by the investigator. Subjects who are participating in other clinical trials Subjects who have received prior chemotherapy including irinotecan.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YongSang Hong, Professor
Organizational Affiliation
Asan Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-gu
Country
Korea, Republic of
Facility Name
Hwasun Hospital
City
Chŏnam
State/Province
Hwasun-gun
Country
Korea, Republic of
Facility Name
Korea Cancer Center Hospital
City
Seoul
State/Province
Nowon-Gu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-Gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients

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