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

NCT ID: NCT01271582

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Stage IV Colorectal Cancer; Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOLFIRI

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

Group Type: EXPERIMENTAL

Irinotecan, 5FU, leucovorin

Intervention Type: DRUG

FOLFIRI regimen every 2 weeks \[irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)\]

Interventions

Irinotecan, 5FU, leucovorin

FOLFIRI regimen every 2 weeks \[irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)\]

Intervention Type: DRUG

Other Intervention Names

CAMPTO (CAMPOSAR)

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tae Won Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YongSang Hong, Professor

Role: STUDY_DIRECTOR

Asan Medical Center

Locations

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Hwasun Hospital

Jeonam, Hwasun-gun, South Korea

Korea Cancer Center Hospital

Seoul, Nowon-Gu, South Korea

Asan Medical Center

Seoul, Songpa-Gu, South Korea

National Cancer Center

Goyang, , South Korea

Countries

South Korea

Other Identifiers

CPT_08_001

Identifier Type: -

Identifier Source: org_study_id