advanced colorectal cancer
Conditions
Interventions
Cetuximab
bi-weekly administration 500mg/m2. Irinitecan is administered as an intravenous infusion at a dose of 120mg/m2 on day 1 and 15. And TS-1 is orally administered on days 1-14 of a 28-day cycle. Adminis
Sponsors
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed advanced or metastatic colorectal cancer. 2) Unresectable advanced or metastatic colorectal cancer 3) EGFR expressed and KRAS wild type in codon 12 and 13 4) Presence of measurable lesion(RECIST ) 5) No prior chemotherapy or radiotherapy for metastatic tumor. 6) Age between 20 to 75 years. 7) ECOG performance status 0. 8) Life expectancy of more than 16 weeks. 9) Adequate hematological (absolute white blood cell count >3000/mm3, neutrophil count >1500/mm3, platelets >100000/mm3, Hb >10 g/dl), hepatic (AST and ALT within 2 times the upper limit of normal for the institution, serum bilirubin level below 1.5 mg/dl) and renal (serum creatinine level below 1.5 mg/dl and BUN under 25 mg/dl) function, with at least one measurable site of disease (>1 cm in at least one dimension). No patients accepted into this had received any prior chemotherapy, except for adjuvant chemotherapy completed more than 6 months before study entry. 10) Written informed consent 11) Protocol was approved by the institutional ethics committee.
Exclusion criteria
Exclusion criteria: Patients are excluded from this trial for any of the following exclusion criteria: symptomatic infectious disease, bleeding tendency, severe heart disease, pre-existing symptomatic peripheral neuropathy, active double cancer, symptomatic ascites, pregnancy, breast feeding, obstructive bowel disease, severe diabetes mellitus requiring insulin or past history of drug allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I study To evaluate feasibility Phase II study Response rate | — |
Countries
Japan
Outcome results
None listed