3rd line or later therapy for unresectable advanced and/or recurrent colorectal cancer
Conditions
Interventions
cetuximab 400 mg/m2 given as 2 hours infusion for the first time, 250mg/m2 as 1 hour infusion for the second time or later. Irinotecan 100mg/m2 repeated every week followed by one week rest or Irinote
Sponsors
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria for eligibility were histologically proven EGFR positive colorectal cancer of; an age of 20 or older; with an unresectable primary tumor or with one or more unresectable metatatic tumor(s); more than two privious treatment by FOLFOX or FOLFIRI regimen; with performance status (ECOG) 0, 1 or 2; the following interval from previous treatments (4 weeks from radiations, 2weeks from a operation with some organ resection, 2 weeks from chemotherapy, 4 weeks from other clinical trial), measurable lesions based on the RECIST; and adequate organ function (a neutrophil count of 1500 or more per cubic millimeter ; a platelet count of at least 100,000 per cubic millimeter; hemoglobin levels of more than 8.0 g per deciliter ;aspartate aminotransferase and alanine aminotransferase levels of 100 or less international unit per litter; a total bilirubin level of no more than 2.0 mg per deciliter; and a serum creatinine level of no more than 1.5 mg per deciliter; expected more than 2 months prognosis; with a written informed consent for this study
Exclusion criteria
Exclusion criteria: The exclusion criteria were symptomatic metastatic brain tumor, uncontrolled massive pleural or abdominal effusion, previous meningitis carcinomatosis, uncontrolled epilepsy, critical mental disturbance, central nervous system disorder, uncontrolled diabtes mellitus, uncontrolled hypertension, active infection treated with antibiotics, antifungal or antiviral drugs, bleeding tendency, symptomatic coagulation abnormality, acute pneumonia, interstitial pneumonitis or pulmonary fibrosis, chronic disease required the treatment with steroid or immune-suppressing drug, diarrhea; with complication of paralytic intestine, bowel obstraction (ileus), previous history of herpersensitivity (Grade 3 or severe) against monoclonal antibody drug, previous history of herpersensitivity against irinotecan, pevious therapy with inhibitor of EGF signal transduction or inhibitor of EGFR, treated with Atazanavir Sulfate, active double cancer within 5 years, Grade 3 or severe neural disturbance, Grade III or IV by NYHA classification or sever cardiac disease within 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival (PFS), overall survival(OS) and safety | — |
Countries
Japan
Contacts
Public ContactShunsuke Kato
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society) Office
Outcome results
None listed