NIPH Clinical Trials Search

UMIN ID: UMIN000002094

Registered date:22/06/2009

Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedColorectal Cancer
Date of first enrollment2008/12/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)FOLFIRI (CPT-11, 5-FU bolus, 5-FU infusional, l-LV)+ Erbitux Cetuximab 400 mg/m2(day1) Cetuximab 250 mg/m2/week, (except day 1) CPT-11 100 or 150 mg/m2/bi-week l-LV 200 mg/m2/bi-week 5-FU/bolus 400 mg/m2/bi-week 5-FU/infusional 2,400 mg/m2/bi-week (day 1-3)


Primary OutcomeResponse rate
Secondary OutcomeOverall survival, progression-free survival, disease control rate, dose intensity, response rate according to internal organs, safety profile

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria(1)Severe bone marrow suppression (2)Wattery diarrhea (3)Severe infectious disease (4)Massive pleural effusion or ascites (5)Comorbidity or history of heart failure (6)Comorbidity or history of interstitial lung disease or pulmonary fibrosis (7)Paralytic or mechanical bowel obstruction (8)Jaundice (9)Patients who is receiving Atazanavir Sulfate (10)History of severe allergy (11)Pregnant or lactating women or women of childbearing potential (12)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) (13)Symptomatic brain metastasis (14)Simultaneous or metachronous double cancers (15)Any other cases who are regarded as inadequate for study enrollment by the investigator.

Related Information


public contact
Name Mai Hatta
Address 65 Tsurumai Showa-ku Nagoya Japan
Telephone 052-744-2442
Affiliation Young Leaders' Program (YLP), Nagoya University School of Medicine See Above
scientific contact
Name Hideyuki Mishima
Address 1-1, Yazakokarimata, Nagakute, Aichi Japan
Telephone 0561-62-3311
Affiliation Aichi Medical University Cancer Center