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

Study Overview
=================
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.

Official Title
-----------------
Investigation of Association Between UGT1A1 Polymorphisms and Irinotecan Toxicity in Korean Patients With Advanced Colorectal or Gastric Cancer Treated With FOLFIRI Regimen

Conditions
-----------------
Stage IV Colorectal Cancer, Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan, 5FU, leucovorin


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOLFIRI<br>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<br>* 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)]<br>* Other names: CAMPTO (CAMPOSAR);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment | During the first cycle of treatment | 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric cancer, Colorecatal cancer, Irinotecan, UGT1A1, Neutropenia