advanced colorectal cancer
Conditions
Interventions
panitumumab
cetuximab
Sponsors
Tsukuba Center Clinical Trial Group(TCTG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age>=20years 2) Patients with histopathologically proven unresectable advanced colorectal adenocarcinoma (including cecal cancer) 3) Patients have failed a prior regimen containing oxaliplatin and fluoropyrimidine. 4) difficulty in combination of CPT-11by physician decision 5) ECOG performance status 0-2. 6) KRAS with wild-type 7) at least 2 weeks must have elapsed since any prior chemotherapy 8) previous history of chemotherapy including cetuximab, or panitumumab 9)Adequate hematologic, renal, hepatic and metabolic function : white blood cell>=2000/mm3 neutrophil count>=1200/mm3, hemoglobin level>=8g/dL, platelet count>=75000/mm3, total bilirubin<=3.0mg/dL, AST and ALT<=200IU/L, serum creatinine<=1.5mg/dL 10) Written informed consent obtained from the patient
Exclusion criteria
Exclusion criteria: 1)having other active malignancies 2) severe complications (uncontrolled diabetes mellitus, interstitial lung disease, pulmonary fibrosis, heart failure ,renal failure, hepatic failure, etc.) 3) having active infections 4) history of severe drug hypersensitivity 5) uncontrollable serious mental problem 7) pregnant or female intend to be pregnant, and male intend to make pregnant. 8) Others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate,time to treatment failureprogression free survival,safety | — |
Countries
Japan
Contacts
Public ContactKoichi Taira
Machida Gastrointestinal Hospital Department of Clinical Oncology
Outcome results
None listed