advanced/metastatic colorectal cancer
Conditions
Interventions
Irinotecan plus S-1 with cetuximab combination therapy Cetuximab 400mg/m2 day1 and then 250mg/m2 day 8,15,22 weekly until PD, or Cetuximab 500mg/m2 day 1, 15, 29 biweekly until PD Irinotecan 100 mg/
BSA]/body/day, day 1-14, q4weeks
Sponsors
NPO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2) Clinically proven unresectable advanced/ metastatic colorectal cancer 3) Previously received on one regimen of oxaliplatin-contained chemotherapy (contained relapse less than 6 months from adjuvant chemotherapy) 4) Presence of at least one measurable lesion (according to the RECIST ver.1.1) 5) Immunohistochemical evidence of EGFR expression, either in the primary tumor or in metastatic tumor lesion 6) KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion 7) Patients unaffected prior therapy At least 4-6 weeks since prior radiotherapy At least 4 weeks since prior operation for organ At least 2 weeks since prior chemotherapy At least 2 weeks since prior immune therapy, cytokine therapy or BRM therapy 8) More than 20 years of age 9) ECOG performance status 0-1 10) Adequate organ function for study treatment WBC>=3000mm3, neutrophils>=1500/mm3 Platelets>=100000/mm3 Hemoglobin>=8.0g/dl AST and ALT<=upper limit of normal (ULN)*2.5 (<=ULN*5 in case of liver metastasis) Total bilirubin<=upper limit of normal (ULN)*2 Creatinine<=upper limit of normal (ULN) 11) Oral food intake possible 12) Life expectancy must be 3 months or longer after the combination therapy 13) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of severe allergy 2) Simultaneous or metachronous double cancers 3) Symptomatic brain metastasis 4) Severe infectious disease 5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 6) Paralytic or mechanical bowel obstruction 7) Massive pleural effusion or ascites 8) Wattery diarrhea 9) Patients who is receiving Atazanavir Sulfate or Flucytosine 10) Pregnant or lactating women or women of childbearing potential 11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate | — |
Countries
Japan
Contacts
Public ContactSatoshi Yuuki
Hokkaido University Hospital Gastroenterology & Hematorogy
Outcome results
None listed