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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019893
Receipt No. R000022856
Scientific Title Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
Date of disclosure of the study information 2015/11/24
Last modified on 2015/11/14

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Basic information
Public title Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
Acronym Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
Scientific Title Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
Scientific Title:Acronym Phase II study of biweekly cetuximab and irinotecan as third-line therapy in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
Region
Japan

Condition
Condition Metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Cetuximab and Irinotecan as third-line treatment in patients with pre-treated KRAS exon2 wild-type metastatic colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival
Overall survival
Pharmacokinetic parameter
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 Cetuximab 500 mg/M2/2week
Irinotecan 150 mg/M2/2week
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Written IC.
Pathologically diagnosed colorectal adenocarcinoma.
Unresectable colorectal cancer.
No KRAS mutation (codon 12 or codon13).
Age over 20 years old and under 75 years.
ECOG PS0-2.
Target lesion(RECIST 1.0).
Previously treated within 2 regimens and
Wihtout cetuximab. at least 2 week rest.
2 months or longer expected survival.
Adequate organ function.
Key exclusion criteria Receive blood infusion, G-CSF within 7days before primary registration.
UGT1A1*28 homo, *6 homo,*28*6
Severe heart disease.
Severe liver disease.
Severe lung disease.
Active gastrointestinal bleeding.
Severe mental disease.
Severe diabetes.
Ileus.
Active infectious disease.
Other active cancer.
Cerebral metastasis.
Icterus .
Severe diarrhea.
Severe allergic reaction for drugs (irinotecan anti-EGFR antibody).
Massive ascites, plerural effusion.
Under treatment with atazanavir.
Past history of treatment with EGFR antibody.
Alcoholic or drug Intoxication.
Hbs antibody positive.
HCV antibody positive.
HIV antibody positive.
A pregnant woman, a woman in breast-feeding, a man who expects his baby.
An inappropriate case judged by docter in charge.
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Mizunuma
Organization The Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name Department of Gastroenterology
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3520-0111
Email nobuyuki.mizunuma@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Shinozaki
Organization The Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name Department of Gastroenterology
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan
TEL 03-3520-0111
Homepage URL
Email eiji.shinozaki@jfcr.or.jp

Sponsor
Institute The Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization The Cancer Institute Hospital, Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 がん研有明病院 (東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 22 Day
Last modified on
2015 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022856

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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