colorectal cancer
Conditions
Interventions
l-LV 200mg/m2 day 1 5-FU/bolus 400mg/m2 day1 5-FU/infusional 2,400mg/m2 day1-2 Panitumumab 6mg/kg day 1 Biweekly or Capecitabine 2,000mg/m2/day day1-7 Panitumumab 6mg/kg day1 Biweekl
Sponsors
Epidemiological and Clinical research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer 2)KRAS wild type 3)Measurable lesion based on RECIST ver1.1. 4)Not appropreate for combination therapy with fluorouracil and oxaliplatin or irinotecan 5)Age of at least 20 years. 6)ECOG PS of 0 - 2 7)Adequate organ functions a)WBC=>2000/mm3 b)Neutrophil=>1000/mm3 c)Platelet count>=7.5*104/mm3 d)Hemoglobin>=8.0 g/dL e)Total bilirubin<=2*ULN f)AST ALT<= 100 lU/L(Liver Met; AST, ALT<=199lU/L) g)Creatinine<=2*ULN h)Urine protein<= 2+ 8)A life expectancy of more than 8 weeks 9) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Symptoms of brain metastasis 2) Uncontrolled diarrhea 3) Ireus 4) Infectious 5) Serious pulmonary diseases (interstitial pneumonia, pulmonary fibrosis or severe pneumothorax) 6) With serious diseases (uncontrolled DM, heart failure, renal failure, and/or liver dysfunction) 7) Ladies pregnant and/or nursing baby, or ladies who have plans to have babies. 8) Carcinomatous menigitis, and/or history of mental disorder 9) Neuropathy of more than grade 3 10) Administration of contraindicative medicines 11) Previously treated by anti-EGFR medicines 12) Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate Progression-free survival Adverse events Biomarkers on clinical examination data | — |
Countries
Japan
Contacts
Public ContactYumi Miyashita
Epidemiological and Clinical research Information Network (ECRIN) ECRIN Data Center
Outcome results
None listed