unresectable metastatic colorectal cancer
Conditions
Interventions
None listed
Sponsors
Kinki University School of Medicine, Department of medical oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1,Age>20y.o. 2,histologically confirmed unresectable mCRC 3,Prior treated with irinotecan, for at least 6weeks or more. 4,Radiographically disease progressed during or within 3 month following irinotecan. 5,Failure from fluoropyrimidine- and oxaliplatin-based chemotherapies. 6,ECOG PS 0-2 7,immunohistochemical evidense of EGFR expression 8,At least 2weeks non therapy since previous therapy 9,Prescence of measurable lession by CT scan or MRI. 10,no prior therapy with EGFR inhibitor 11,adequate organ function White blood cell count>3,000/m3 Hb>9.0g/dl Plt>100,000/m3 T-Bil<1.5mg/dl AST, ALT<200IU/l Serum creatinine<1.5mg/dl 12,Life expectancy of at least 3 months 13,Written informed consent
Exclusion criteria
Exclusion criteria: 1,symptomatic brain metastasis 2,serious pleural effusion or ascites 3,active infection 4,uncontrolled heart disease, diabetes and hypertension 5,diarrhea, watery stool 6,uncontrolled colonic or small bowel disorder 7,intestinal pneumonia of lung fibrosis 8,pregnancy or lactation period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate between higher and lower amphiregulin group | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate Time to progression Overall survival | — |
Countries
Japan
Outcome results
None listed