NIPH Clinical Trials Search

UMIN ID: UMIN000006643

Registered date:01/11/2011

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced colorectal cancer
Date of first enrollment2011/12/20
Target sample size120
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Panitumumab + Irinotecan Cetuximab + Irinotecan


Primary OutcomeProgression free survival
Secondary OutcomeOverall survival, response rate, disease control rate, safety,translational biomarker research

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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


public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.304-1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Daisuke Sakai
Address 2-2 Yamadaoka, Suita City, Osaka. 565-0871, JAPAN Japan
Telephone 06-6879-2641
Affiliation Osaka University, Graduate School of Medicine. Department of Frontier Science for Cancer and Chemotherapy