None listed
Conditions
Interventions
Drug : According to the test result of UGT1A1, irinotecan with 300 mg/m2 and 250 mg/m2 doses of 0 defective allele and 1 defective allele, respectively, is given every 2 weeks. A determined dose of Ir
glucose injection solution or electrolyte maintenance solution, and infuse it intravenously over 90 minutes.
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who voluntarily and in writing consent to participate in this study 2. Male and female patients over 19 years old 3. Patients with histologically confirmed metastatic or recurrent colorectal cancer -Patients who received second or later-line chemotherapy including 5-fluorouracil, oxaliplatin, and irinotecan as anticancer drugs. Targeted therapies and immunooncology drugs are also permitted. -Adjuvant chemotherapy is considered as primary chemotherapy if relapse is confirmed within 6 months of completion. -Patients who have had a complete or partial response or have had stable lesions for more than 24 weeks through chemotherapy, including previous irinotecan. -Patients whose imaging progress has been confirmed during chemotherapy including irinotecan or within 6 months after the end of chemotherapy -Patients 12 weeks or more after the last dose of chemotherapy, including irinotecan. 4. Patients with Eastern cooperative oncology group (ECOG) performance status = 1 5. Patients with an expected survival period of 12 weeks or more 6. Patients with evaluable lesions in Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) 7. Patients whose proper hematologic function, kidney and liver function are confirmed by the following criteria -White blood count (WBC) of 3,000/µL or more -Absolute neutrophil count (ANC) of 1,000/µL or more -Platelet count is over 100,000/µL -Hemoglobin count is over 9.0 g/dL -Bilirubin is 1.5 times or less of the upper limit of normal (ULN) -Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are 3 times or less of ULN (5 times or less of ULN if liver metastasis is present) -Serum creatinine is 1.5 times less than ULN 8. A person who understands the contents of the clinical trial, is cooperative in the trial, and is considered to be able to participate until the end of the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Patients who received chemotherapy or immunotherapy within 2 weeks prior to screening 3. Patients undergoing major surgery or radiation therapy within 4 weeks prior to screening 4. You have a history of malignancy within 3 years of registration. However, basal or squamous cell skin cancer, cervical epithelial tumor, breast epithelial cancer, or prostate-specific antigen <0.01 ng/mL, except for prostate cancer treated with surgery or RT. 5. Patients with symptomatic central nervous system metastases (except for the case where systemic corticosteroid administration was stopped at least 4 weeks prior to baseline and neurologically stable for 4 weeks or more) 6. Significant cardiovascular disease, including congestive heart failure of the New York Heart Association Grade III or IV, myocardial infarction within 6 months of enrollment, unstable angina, poorly controlled heart arrhythmias, or stroke within the past 6 months. 7. Child-Pugh B or C patients with evidence of cirrhosis. In the case of HBV or HCV-related chronic hepatitis or cirrhosis Child-Pugh A, if the liver function is stably maintained through drug treatment, it may be registered in a clinical trial. 8. Other uncontrolled concomitant medical conditions, including systemic fungal, bacterial, or viral infections 9. People with the following diseases or conditions -Chronic inflammatory bowel disease -Patients with severe intestinal palsy and intestinal obstruction requiring interventional treatment -Patients with interstitial pneumonia or pulmonary fibrosis -Patients with large amounts of ascites and pleural effusion -Patients with diarrhea -Dialysis patients -Patients with a history of hypersensitivity to irinotecan or its components -Patients receiving atazanavir sulfate or St. John's wort 10. A person deemed inappropriate by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | — |
Countries
Korea, Republic of
Contacts
Public ContactMoon Ki Choi
National Cancer Center
Outcome results
None listed