Metastatic colorectal cancer
Conditions
Interventions
first line chemotherpy FOLFIRI+Cetuximab (Cetuximab 500mg/m2/bi-week CPT-11 150mg/m2/bi-week l-LV 200mg/m2/bi-week 5-FU/bolus 400mg/m2/bi-week 5-FU/infusional 2,400mg/m2/bi-week (day 1
Sponsors
Gunma University Graduate school of Medicine Department of General surgical science clinical study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with histologically proven colorectal cancer 2) Metastatic colorectal cancer with EGFR expressed 3) Metastatic colorectal cancer with KRAS wild-type 4) No prior chemotherapy (Patients who recieved treatment including oxaliplatin or fluoropyrimidine type anti-cancer drugs before 24 weeks are eligibled) 5) 20 years-old<= 6) PS:0-1(EGOG performance status score) 7) Presence of measurable lesion (RECIST Ver.1.1) 8) Patients who are tolerant to oral administration 9) Patients have enough organ function for study treatment i leucocytes>=3,000/mm3,neutrophils>=1,500/mm3 ii platelets>=100,000/mm3 iii hemoglobin>=9.0g/dl iv AST(GOT),ALT(GPT),ALP<=twice as upper limit of normal (ULN)(5 timesif showing liver disease) v total blirubin<=half time as upper limit of normal(ULN) vi creatinine<=half time as upper limit of normal(ULN) 10) Life expectancy of more than 3 months 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease-free interval 2) Symptomatic brain metastases 3) Severe myelosuppression 4) Watery diarrhea 5) Severe infectious disease 6) Interstitial lung disease or pulmonary fibrosis 7) Comorbidity or history of severe heart failure 8) Sensory alteration or paresthesia interfering with function 9) Need to drain malignant coelomic fluid 10) Severe comorbidity 11) Paralytic or mechanical bowel obstruction 12) Jaundice 13) Patient taking Atazanavir sulphate 14) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 15) History of severe allergy 16) History of allergy for Cetuximab, Bevacizumab, fluoropyrimidine, irinotecan, oxaliplatin and other platinating agent 17) Prior treatment of Cetuximab, Bevacizumab, fluoropyrimidine, irinotecan and oxaliplatin Any other cases who are regarded as inadequate for study enrollment by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Progression free survival (PFS1+PFS2): PFS during first-line (PFS1) and PFS during second-line (PFS2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival during first-line (PFS1) Progression free survival during second-line (PFS2) Response rate during first-line (RR1) Response rate during second-line (RR2) Tumor shrinkage rate at 8 weeks in first-line Overall survival (OS) Survival beyond progression (SBP) Safety | — |
Countries
Japan
Contacts
Public ContactHiroyuki Kuwano
Gunma University Graduate school of Medicine Department of General surgical science
Outcome results
None listed