Colorectal cancer
Conditions
Interventions
FOLFIRI+panitumumab
FOLFIRI+bevacizumab
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histopathologically proven metastatic or locally advanced colorectal adenocarcinoma 2) presence of radiographically or clinically confirmed disease progression during previous first-line chemotherapy using oxaliplatin, fluoropyrimidine, bevacizumab, or progression within 3 months after the last chemotherapy 3) KRAS with wild-type 4) Age>=20years 5) ECOG performance status 0-2. 6) The presence of evaluable disease, as defined by the RECIST criteria. 7) Treatment free interval with more than 2 weeks after last radiotherapy 8) Adequate bone marrow reserve (neutrophil count>=1200/mm3, platelet count>=75000/mm3, Hemoglobin level>=8g/dl), adequate hepatic function (AST and ALT<=100IU/L, or AST,ALT<=200IU/L with liver metastases, total bilirubin<=1.5mg/dl), Adequate renal function (serum creatinine<=1.5mg/dL, fulfill at least one of the following criteria; urine dipstick 1+ or less, urine protein creatinine (UPC) 1 or less, or 24-hour urine protein 1000mg or less) 9) Expected survival>= 90 days 10) Written informed consent obtained from the patient
Exclusion criteria
Exclusion criteria: 1) previous history of chemotherapy including irinotecan, cetuximab, or panitumumab 2) symptomatic brain metastasis or brain metastasis with under medication 3) intestinal obstruction 4) uncontrollable ascites or pleural effusion 5) uncontrollable diarrhea 6) having other active malignancies 7) having active infections 8) pulmonary fibrosis or interstitial pneumonia 9) serious comorbidities, such as uncontrollable diabetes mellitus, severe heart disease (NYHA>III), renal failure, and liver failure 10) History of arterial thromboembolic events such as unstable angia, myocardial infarction, brain hemorrhage, and brain infarction within 6 months. 11) having wound healing problem (excluding central venous port) 12) History of major surgery within 28 days or 14 days after colostomy. 13) Meningitis carcinomatosis or uncontrollable seizures, serious mental problem or neurologic disorders 14) continuous steroid administration 15) serious drug allergy 16) HIV infection 17) Pregnant or lactating female 18) Other serious medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression freer survival, response rate, safety, translational research | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed