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

Phase 4

• Conditions: Gastric Cancer; Stage IV Colorectal Cancer
• Interventions: Drug: Irinotecan, 5FU, leucovorin

• Registration Number: NCT01271582
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2014-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-27
• Last Update Posted: 2019-01-29
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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)

Trial Locations

Locations (5)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of

Hwasun Hospital; 🇰🇷 Chŏnam, Hwasun-gun, Korea, Republic of

Korea Cancer Center Hospital; 🇰🇷 Seoul, Nowon-Gu, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of

National Cancer Center; 🇰🇷 Goyang, Korea, Republic of