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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01271582
• Other study ID #: CPT_08_001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2009
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 2019
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Gastric Cancer
• Stage IV Colorectal Cancer
• Stomach Neoplasms

Intervention

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)]

Locations

Country	Name	City	State
Korea, Republic of	Hwasun Hospital	Chonam	Hwasun-gun
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Asan Medical Center	Seoul	Songpa-Gu
Korea, Republic of	Korea Cancer Center Hospital	Seoul	Nowon-Gu
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment	During the first cycle of treatment	2 weeks
Secondary	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
Secondary	Association between grade 3/4 diarrhea and UGT1A1 polymorphism	During the first cycle of treatment	2 weeks
Secondary	Progression-free survival	The time from registration to objective tumor progression or death	6 months (average)