colorectal cancer
Conditions
Interventions
Cetuximab: Weekly administration 400 mg/m2 for the 1st time (day1), 250mg/m2/week for the 2nd time or another (day8,15,..) TS-1 is orally administered b.i.d. on days 1-14 and CPT-11 is intravenously
Sponsors
Toho University school of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed colorectal cancer 2.KRAS wild type 3.Patients with no prior chemotherapy 4. Age >=20 5. ECOG performance status 0 or 1 6.Life expectancy of more than 3 months 7. Sufficient organ functions WBC 3,000/mm3-12,000/mm3 Neurtophils >=1,500/mm3 Platelets >=100,000/mm3 Hemoglobin >=9.0g/dl Total bilirubin <=1.5mg/dl GOT and GPT <=100IU/l Creatinine <1.2mg/dl Creatinine Crearance >=60ml/min 8.the case can eat 9Written IC
Exclusion criteria
Exclusion criteria: 1. Multiple malignancies 2. Serious complications(intestinal paralysis and intestinal obstruction, interstitial pneumonia, pulmonary fibrosis,renal failure, cardiac failure , liver failure) 3.Infection 4.Diarrhea 5. mechanical bowel obstruction 6.Uncontrolable pleural effusion or ascites requiring 7.History of serious drug hypersensitivity 8.Need to treatment with flucytosine, atazanavir sulfate 9.Fresh bleeding of digestive organs 10.Cirrhosis, Icterus 11.Evidence of psychiatric disability interfering with enrollment to clinical trial 12.Need to treatment with heart failure, ischemic heart disease or arrhythmia 13.Uncontrolable diabetes 14.Symptomatic brain metastasis 15.Pregnant or lactating women or women of childbearing potential. 16.Patients judged inappropriate for this study by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose Recommended dose | — |
Countries
Japan
Contacts
Public ContactJunichi Koike
Toho University school of Medicine Division of general and gastroenterological surgery, Department of Surgery (Omori)
Outcome results
None listed