NIPH Clinical Trials Search

UMIN ID: UMIN000001668

Registered date:31/01/2009

Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on KRAS mutation status (T-CORE0801)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studied3rd line or later therapy for unresectable advanced and/or recurrent colorectal cancer
Date of first enrollment2009/02/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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 Irinotecan 150mg/m2 repeated every two weeks.


Primary Outcomeresponse rate
Secondary Outcomeprogression free survival (PFS), overall survival(OS) and safety

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaThe 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.

Related Information


public contact
Name Shunsuke Kato
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan Japan
Telephone 022-717-8599
Affiliation NPO T-CORE (Tohoku Clinical Oncology Research and Education Society) Office
scientific contact
Name Hideki Shimodaira
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan Japan
Telephone 022-7171-8547
Affiliation Institute of Development, Aging and Cancer, Tohoku University Department of Clinical Oncology