Metastatic colorectal cancer
Conditions
Interventions
Cetuximab + Irinotecan therapy Cetuximab Weekly schedule 400mg/(initial dose):250mg/m2(Maintenance dose) every week or Bi-weekly schedule 500mg/m2 every 2 weeks Irinotecan 150mg/m2 every 2
Sponsors
Hyogo Prefectural Nishinomiya Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with histologically proven colorectal cancer (2)KRAS wild type (3)Metastatic colorectal cancer with measurable lesion(RECIST ver.1.1) (4)Patients who were treated Cetuximab and the other regimen after Cetuximab (Exclude cetuxumab) for metastatic colorectal cancer.(Best response was more than stable disease with Cetuximab treatment.) (5)Refractory to or intolerant of prior fluorinated pyrimidine , oxaliplatin and irinotecan. (6)Age equal more 20 years old (7)ECOG Performance Status 0-2 (8)Vital organ functions are preserved within 14 days prior to entry. 1)WBC:>=3,000/mm3 2)Neu:>=1,500/mm3 3)PLT:>=80,000/mm3 4)Hb:>=8.0g/dL 5)Total bilirubin:<=2.0mg/dL 6)AST,ALT:<=ULN*2.5(Patients with liver metastasis:<=ULN*5.0) 7)Serum creatinine:<=ULN*1.5 8)The Patient does not have electrocardiography abnormality to need treatment. (9)Life expectancy of more than 3 months. (10)Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Prior panitumumab treatment. (2) Contraindications of irinotecan. (3) Brain metastasis with symptom. (4) Systemic infection. (5) History of severe allergy. (6) Active double cancer. (7)Systemic administration of corticosteroids. (8) Severe mental illness. (9) Patients who are judged inappropriate for the entry into the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival Progression Free Survival Safety Response rate according to the prior Cetuximab regimen Response rate according to the interval from prior Cetuximab treatment | — |
Countries
Japan
Contacts
Public ContactMutsumi Fukunaga
Hyogo Prefectural Nishinomiya Hospital Department of surgery
Outcome results
None listed