metastatic colorectal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Colorectal cancer histlogical proven 2) Unresectable 3) KRAS wild type 4) Prior treatment was L-OHP-based or CPT-11 based chemotherapy 5) No prior panitumumab/cetuximab 6) More than 20 years old Expect to survive more than 3 months ECOG performance status: 0-2 7) Organs (bone marrow, lung, liver, and kidney) failure is not advanced. i) Neutrophil count: more than 1,500 / mm3 ii)Platelet: more than 100,000 / mm3 iii)Hemoglobin: more than 8.0g/dl iv)Serum total bilirubin : less than 2.0 mg / dl v)Serum creatinine : less than 1.5 mg / dl 8) ECG no abnormalities in 28 days before 9) Lesion measured by RECIST in 10) Written patient consent was obtained from patients.
Exclusion criteria
Exclusion criteria: 1) Advanced pleural effusion, ascites 2) CNS metastases 3) Infection 4) Diarrhea (watery stool) 5) Heart disease as a clinical problem 6) Severe complications (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, it is difficult to control diabetes, heart failure, kidney failure, liver failure etc.) 7) Active double cancer 8) Severe mental disorder 9) Irinotecan, oxaliplatin, panitumumab history of hypersensitivity to 10) Treatment with atazanavir sulfate 11) Pregnant and lacting women 12) Severe drug allergy 13) Judged unfit to by doctors in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate:RR | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Overall survival :OS Progression free survival :PFS | — |
Countries
Japan
Contacts
Yokohama city university Department of surgery