rechallenge high-dose irinotecan with UGT1A1 genotype in metastatic colorectal cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0005303
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 37
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease control rate
- Secondary Outcome Measures
Name Time Method progression-free survival