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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002094
Receipt No. R000002513
Scientific Title Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer: EGFR positive and KRAS wild type
Date of disclosure of the study information 2009/06/22
Last modified on 2018/09/20

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Basic information
Public title Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer:
EGFR positive and KRAS wild type
Acronym Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer:
EGFR positive and KRAS wild type
Scientific Title Multicenter PhaseII study of Combination FOLFIRI with Erbitux in advanced/metastatic colorectal cancer:
EGFR positive and KRAS wild type
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideyuki Mishima
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mai Hatta
Organization Young Leaders&#39; Program (YLP), Nagoya University School of Medicine
Division name See Above
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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%).
 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 11 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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