UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type
Title of the study (Brief title)	Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This study is designed to evaluate efficacy of cetuximab plus FOLFIRI regimen in Japanese patients with EGFR-detectable and KRAS wild type metastatic colorectal carcinoma
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Overall survival, progression-free survival, disease control rate, dose intensity, response rate according to internal organs, safety profile

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients with histologically proven colorectal cancer (2)EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity (3)KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed (4)Curatively unresectable mCRC patients who had received and failed at least one regimen of oxaliplatin-contained chemotherapy (5)Age 20 years<= (6)ECOG performance status 0-1 (7)Presence of at least one measurable lesion (according to the RECIST) (8)Prior chemotherapy was done in the first study treatment before at least 28days (9)Patiens have enough organ function for study treatment 1. WBC>=3,000/mm3 , Neurtophils>=1,500/mm3 2. Platelets>=100,000/mm3 3. Hemoglobin>=9.0g/dl 4. Total bilirubin<=upper limit of normal (ULN)*3 5. AST and ALT<=upper limit of normal (ULN)*3 (<=ULN*5 in case of liver metastasis) 6. Creatinine<=upper limit of normal (ULN)*2 (10)Life expectancy of 3 months (11)Written informed consent
Key exclusion 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.
Target sample size	50

Research contact person
Name of lead principal investigator	Hideyuki Mishima
Organization	Aichi Medical University
Division name	Cancer Center
Address	1-1, Yazakokarimata, Nagakute, Aichi
TEL	0561-62-3311
Email	hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person	Mai Hatta
Organization	Young Leaders' Program (YLP), Nagoya University School of Medicine
Division name	See Above
Address	65 Tsurumai Showa-ku Nagoya
TEL	052-744-2442
Homepage URL
Email	m-hatta@med.nagoya-u.ac.jp

Sponsor
Institute	Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization	Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 06 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 11 Month 15 Day
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date	2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Anticancer Res. 2014 Apr;34(4):1967-73. Results:Sixty-seven patients (59.8%) were EGFR-positive and KRAS wild-type. The mean age of the enrolled patients (n=60) was 62.6 years (range=37-82 years). The response rate was 31.7% and stable disease was observed in 53.3%. No objective response was observed in patients with BRAF or PIK3CA mutations. The median PFS and OS were 7.4 and 18.2 months, respectively. Grade-3/4 adverse events were leucopenia (26.7%), neutropenia (43.3%), paronychia (10.0%), fissure (10.0%) and acne-like rash (5.0%).
Other related information	Multicenter phase II study of second-line cetuximab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI) in KRAS wild-type metastatic colorectal cancer: the FLIER study. Iwamoto S, Hazama S, Kato T, Miyake Y, Fukunaga M, Matsuda C, Bando H, Sakamoto J, Oba K, Mishima H.

Management information
Registered date	2009 Year 06 Month 19 Day
Last modified on	2018 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002513