advanced/metastatic colorectal cancer
Conditions
Interventions
Irinotecan with biweekly cetuximab combination chemotherapy Cetuximab biweekly administration 500mg/m2(day1,15,29, , , ) Irinotecan biweekly administration 150mg/m2(day1,15,29, , ,)
Sponsors
NPO FMPC (Future Medicine Promoting Consortium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically proven colorectal cancer and clinically proven unresectable advanced and/or metastatic colorectal cancer. 2) EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity. 3) Presence of at least one measurable lesion. (according to the RECIST) 4) ECOG performance status 0-1. 5) Patients who had previously received on one regimen of oxaliplatin-contained chemotherapy. (contained neo adjuvant and adjuvant chemotherapy. ) 6) Patients who had received no prior cetuximab-contained chemotherapy, regardless bevacizumab-contained chemotherapy. 7) Patients unaffected prior chemotherapy. 8) above 20 years old 9) Life expectancy must be 3 months or longer after chemotherapy. 10) Written informed consent. 11) KRAS wild type in the primary or metastatic tumor tissue is confirmed. 12) Patiens have enough organ function for study treatment. WBC>=3,000 /mm3 , Neutrophils>=1,500/mm3 Platelets>=100,000/mm3 Hemoglobin>=8.0g/dl AST and ALT<=upper limit of normal (ULN)*2 (<=ULN*3 in case of liver metastasis) Total bilirubin<=upper limit of normal (ULN)*2 Creatinine<=upper limit of normal (ULN)*2 Electrocardiogram is normal or slight symptons without treatment.
Exclusion criteria
Exclusion criteria: 1)history of severe allergy 2)severe complications paralytic or mechanical bowel obstruction interstitial lung disease pulmonary fibrosis heart failure liver failure renal insufficiency 3)Patients who had received at least cetuximab contained chemotherapy 4)Patients who are impossible to receive irinotecan contained chemotherapy severe infectious disease watery diarrhea massive pleural effusion or ascites Jaundice Patients who is receiving Atazanavir Sulfate 5)Pregnant or lactating women or women of childbearing potential 6)Symptomatic brain metastasis 7)Patients with active double cancer 8)Patients who are considered unfit for enrollment in the study because of mental illness, etc. of clinical relevance 9)Patients with heart disease of clinical relevance 10)Inadequate physical condition, as diagnosed by primary physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of toxicity profile Disease control rate Over all survival Progression free survival | — |
Countries
Japan
Contacts
Public ContactSafumi Saiki
NPO FMPC (Future Medicine Promoting Consortium) The secretariat
Outcome results
None listed