colorectal cancer
Conditions
Interventions
Cetuximab 500 mg/m2/biweekly CPT-11 150 mg/m2/biweekly
Sponsors
Kitasato University East Hospital Department of gastroenterological surgery, Department of gastroenterology
Kitasato University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.pathologically diagnosed colorectal cancer. 2.EGFR positive(without K-ras mutation) 3.ECOG PS0-2. 4.target lesion(RECIST 1.0) 5.previously treated within 2 regimens and wihtout cetuximab. at least 2 week rest. 6.3 months or longer expected survival 7.age over 20 years old. 8.adequate organ function. 9.written IC.
Exclusion criteria
Exclusion criteria: 1.severe heart disease. 2.severe liver disease. 3.severe lung disease. 4.active gastrointestinal bleeding. 5.severe mental disease. 6.severe diabetes/. 7.ileus. 8.active infectious disease. 9.other active cancer. 10.cerebral metastasis. 11.icterus 12.severe diarrhea. 13.severe allergic reaction for drugs 14.massive ascites, plerural effusion. 15.under treatment with atazanavir 16.a pregnant woman, a woman in breast-feeding, a man who expects his baby. 17.an inappropriate case judged by docter in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate Compliance Progression-free survival Overall survival Adverse events | — |
Countries
Japan
Outcome results
None listed