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

Asan Medical Center

Status and phase: Unknown; Phase 4

Conditions: Gastric Cancer; Stage IV Colorectal Cancer

Treatments: Drug: Irinotecan, 5FU, leucovorin

Study type: Interventional

Funder types: Other

Identifiers

NCT01271582

CPT_08_001

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

  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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

FOLFIRI

Experimental group

Description:

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

Treatment:

Drug: Irinotecan, 5FU, leucovorin