Colorectal Cancer
Conditions
Interventions
FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Erbitux Cetuximab 400 mg/m2(day1) Cetuximab 250 mg/m2/week, (except day 1) CPT-11 100 or 150 mg/m2/bi-week l-LV 200
Sponsors
Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with histologically proven colorectal cancer (2)EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity (3)KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed (4)Curatively unresectable mCRC patients who had received and failed at least one regimen of oxaliplatin-contained chemotherapy (5)Age 20 years<= (6)ECOG performance status 0-1 (7)Presence of at least one measurable lesion (according to the RECIST) (8)Prior chemotherapy was done in the first study treatment before at least 28days (9)Patiens have enough organ function for study treatment 1. WBC>=3,000/mm3 , Neurtophils>=1,500/mm3 2. Platelets>=100,000/mm3 3. Hemoglobin>=9.0g/dl 4. Total bilirubin<=upper limit of normal (ULN)*3 5. AST and ALT<=upper limit of normal (ULN)*3 (<=ULN*5 in case of liver metastasis) 6. Creatinine<=upper limit of normal (ULN)*2 (10)Life expectancy of 3 months (11)Written informed consent
Exclusion criteria
Exclusion criteria: (1)Severe bone marrow suppression (2)Wattery diarrhea (3)Severe infectious disease (4)Massive pleural effusion or ascites (5)Comorbidity or history of heart failure (6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (7)Paralytic or mechanical bowel obstruction (8)Jaundice (9)Patients who is receiving Atazanavir Sulfate (10)History of severe allergy (11)Pregnant or lactating women or women of childbearing potential (12)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) (13)Symptomatic brain metastasis (14)Simultaneous or metachronous double cancers (15)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 |
|---|---|
| Overall survival, progression-free survival, disease control rate, dose intensity, response rate according to internal organs, safety profile | — |
Countries
Japan
Contacts
Public ContactMai Hatta
Young Leaders&#39; Program (YLP), Nagoya University School of Medicine See Above
Outcome results
None listed