WJOG6510G : Randomized phase II study of panitumumab + irinotecan versus cetuximab + irinotecan in Patients Wild-Type KRAS Metastatic Colorectal Cancer Following Treatment with Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy

UMIN ID: UMIN000006643

Registered date:01/11/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced colorectal cancer
• Date of first enrollment: 2011/12/20
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Panitumumab + Irinotecan
Cetuximab + Irinotecan

Outcome(s)

• Primary Outcome: Progression free survival
• Secondary Outcome: Overall survival, response rate, disease control rate, safety,translational biomarker research

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) previous history of chemotherapy including cetuximab, or panitumumab 2) Final dose of prior CPT-11 <100mg/m2 3) having other active malignancies 4) severe complications (gastrointestinal bleeding, ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, ischemic heart disease, arrhythmia, heart failure renal failure, hepatic failure, glaucoma, uncontrolled diabetes mellitus, etc.) 5) having active infections 6) uncontrollable diarrhea 7) moderate/severe pleural effusion or ascites 8) history of severe drug hypersensitivity 9) continuous steroid administration 10) Treatment with atazanavir sulfate 11) repeated gastrointestinal bleeding 12) uncontrollable seizures, serious mental problem 13) Symptomatic brain metastasis or meningitis carcinomatosis. 14) Pregnant or female intend to be pregnant, and male intend to make pregnant. 15) Others.

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None