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