advanced colorectal cancer
Conditions
Interventions
Panitumumab + Irinotecan
Cetuximab + Irinotecan
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histopathologically proven unresectable advanced colorectal adenocarcinoma (including cecal cancer) 2) Patients have failed a prior regimen containing irinotecan, and a prior regimen containing oxaliplatin and fluoropyrimidine. 3) KRAS with wild-type 4) Age>=20years 5) ECOG performance status 0-2. 6) The presence of evaluable disease, as defined by the RECIST criteria v1.1. 7) Adequate hematologic, renal, hepatic and metabolic function : neutrophil count>=1500/mm3, platelet count>=100000/mm3, Hemoglobin level>=8g/dL, total bilirubin<=1.5mg/dL, AST and ALT<=100IU/L, or AST,ALT<=200IU/L with liver metastases, serum creatinine<=1.5mg/dL 8) Expected survival>=90 days 9) Written informed consent obtained from the patient
Exclusion criteria
Exclusion criteria: 1) previous history of chemotherapy including cetuximab, or panitumumab 2) Final dose of prior CPT-11 <100mg/m2 3) having other active malignancies 4) severe complications (gastrointestinal bleeding, ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, ischemic heart disease, arrhythmia, heart failure renal failure, hepatic failure, glaucoma, uncontrolled diabetes mellitus, etc.) 5) having active infections 6) uncontrollable diarrhea 7) moderate/severe pleural effusion or ascites 8) history of severe drug hypersensitivity 9) continuous steroid administration 10) Treatment with atazanavir sulfate 11) repeated gastrointestinal bleeding 12) uncontrollable seizures, serious mental problem 13) Symptomatic brain metastasis or meningitis carcinomatosis. 14) Pregnant or female intend to be pregnant, and male intend to make pregnant. 15) Others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, response rate, disease control rate, safety,translational biomarker research | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed