Gastric Cancer, Stage IV Colorectal Cancer
Conditions
Keywords
Colorecatal cancer, Gastric cancer, Irinotecan, UGT1A1, Neutropenia
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.
Interventions
DRUGIrinotecan, 5FU, leucovorin
FOLFIRI regimen every 2 weeks \[irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)\]
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between UGT1A1 polymorphism and grade 3/4 neutropenia after 1st cycle of FOLFIRI treatment | 2 weeks | During the first cycle of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between UGT1A1 polymorphism and grade 3/4 neutropenia in all treatment duration | 24 weeks | During all treatment period(during 12 cycle, each 2 weeks) |
| Association between grade 3/4 diarrhea and UGT1A1 polymorphism | 2 weeks | During the first cycle of treatment |
| Progression-free survival | 6 months (average) | The time from registration to objective tumor progression or death |
Countries
South Korea
Outcome results
None listed