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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01271582

Collaborator

(none)

1,500

Enrollment

Locations

Arm

131

Duration (Months)

300

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Colorectal Cancer Gastric Cancer	Drug: Irinotecan, 5FU, leucovorin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FOLFIRI Patients with colorectal cancer or gastric cancer will be treated with FOLFIRI(Irinotecan, 5FU, leucovorin) regimen upto 12 cycles. (Single arm study)	Drug: Irinotecan, 5FU, leucovorin 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)] Other Names: CAMPTO (CAMPOSAR)

Arm

Intervention/Treatment

Experimental: FOLFIRI

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

Drug: Irinotecan, 5FU, leucovorin

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)]

Other Names:

CAMPTO (CAMPOSAR)

Outcome Measures

Primary Outcome Measures

Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment [2 weeks]
During the first cycle of treatment

Secondary Outcome Measures

Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration [24 weeks]
During all treatment period(during 12 cycle, each 2 weeks)
Association between grade 3/4 diarrhea and UGT1A1 polymorphism [2 weeks]
During the first cycle of treatment
Progression-free survival [6 months (average)]
The time from registration to objective tumor progression or death

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul	Gangnam-gu	Korea, Republic of
2	Hwasun Hospital	Chŏnam	Hwasun-gun	Korea, Republic of
3	Korea Cancer Center Hospital	Seoul	Nowon-Gu	Korea, Republic of
4	Asan Medical Center	Seoul	Songpa-Gu	Korea, Republic of	05505
5	National Cancer Center	Goyang		Korea, Republic of