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)

UMIN ID: UMIN000001668

Registered date:31/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 3rd line or later therapy for unresectable advanced and/or recurrent colorectal cancer
• Date of first enrollment: 2009/02/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: progression free survival (PFS), overall survival(OS) and safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
• Source(s) of Monetary Support: NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)