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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002761
Receipt No. R000003272
Scientific Title Phase II trial of irinotecan with biweekly cetuximab in unresectable advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on EGFR positive and KRAS wild type.(i-BEX trial)
Date of disclosure of the study information 2009/11/16
Last modified on 2014/05/23

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Basic information
Public title Phase II trial of irinotecan with biweekly cetuximab in unresectable advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on EGFR positive and KRAS wild type.(i-BEX trial)
Acronym Phase II trial of irinotecan with biweekly cetuximab in advanced and/or metastatic colorectal cancer.(i-BEX trial)
Scientific Title Phase II trial of irinotecan with biweekly cetuximab in unresectable advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on EGFR positive and KRAS wild type.(i-BEX trial)
Scientific Title:Acronym Phase II trial of irinotecan with biweekly cetuximab in advanced and/or metastatic colorectal cancer.(i-BEX trial)
Region
Japan

Condition
Condition advanced/metastatic colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate safety and efficacy of irinotecan with biweekly cetuximab combination chemotherapy in patients with EGFR positive and KRAS wild type unresectable advanced and/or metastatic colorectal cancer, who had received oxaliplatin-contained chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Rate of toxicity profile
Disease control rate
Over all survival
Progression free survival

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 Irinotecan with biweekly cetuximab combination chemotherapy
Cetuximab biweekly administration 500mg/m2(day1,15,29, , , )
Irinotecan biweekly administration 150mg/m2(day1,15,29, , ,)
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 and clinically proven unresectable advanced and/or metastatic colorectal cancer.
2) EGFR expression in the primary or metastatic tumor tissue is confirmed by immunohistochemical evaluation regardless of intensity.
3) Presence of at least one measurable lesion. (according to the RECIST)
4) ECOG performance status 0-1.
5) Patients who had previously received on one regimen of oxaliplatin-contained chemotherapy. (contained neo adjuvant and adjuvant chemotherapy. )
6) Patients who had received no prior cetuximab-contained chemotherapy, regardless bevacizumab-contained chemotherapy.
7) Patients unaffected prior chemotherapy.
8) above 20 years old
9) Life expectancy must be 3 months or longer after chemotherapy.
10) Written informed consent.
11) KRAS wild type in the primary or metastatic tumor tissue is confirmed.
12) Patiens have enough organ function for study treatment.
WBC>=3,000 /mm3 ,
Neutrophils>=1,500/mm3
Platelets>=100,000/mm3
Hemoglobin>=8.0g/dl
AST and ALT<=upper limit of normal (ULN)*2 (<=ULN*3 in case of liver metastasis)
Total bilirubin<=upper limit of normal (ULN)*2
Creatinine<=upper limit of normal (ULN)*2
Electrocardiogram is normal or slight symptons without treatment.
Key exclusion criteria 1)history of severe allergy
2)severe complications
paralytic or mechanical bowel obstruction
interstitial lung disease
pulmonary fibrosis
heart failure
liver failure
renal insufficiency
3)Patients who had received at least cetuximab contained chemotherapy
4)Patients who are impossible to receive
irinotecan contained chemotherapy
severe infectious disease
watery diarrhea
massive pleural effusion or ascites
Jaundice
Patients who is receiving Atazanavir Sulfate
5)Pregnant or lactating women or women of childbearing potential
6)Symptomatic brain metastasis
7)Patients with active double cancer
8)Patients who are considered unfit for enrollment in the study because of mental illness, etc. of clinical relevance
9)Patients with heart disease of clinical relevance
10)Inadequate physical condition, as diagnosed by primary physician
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Mekata
Organization Shiga University of Medical Science
Division name Department of Surgery
Zip code
Address Setatsukinowa-cho,Otsu-city,Shiga
TEL 077-548-2238
Email hqchemo@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Safumi Saiki
Organization NPO FMPC (Future Medicine Promoting Consortium)
Division name The secretariat
Zip code
Address 200-1 Ohazauenoda,Hino-machi,Gamo-gun,Shiga
TEL 077-548-2238
Homepage URL
Email hqchemo@belle.shiga-med.ac.jp

Sponsor
Institute NPO FMPC (Future Medicine Promoting
Consortium)
Institute
Department

Funding Source
Organization NPO FMPC (Future Medicine Promoting
Consortium)
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 11 Month 16 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 Open public recruiting
Date of protocol fixation
2009 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 13 Day
Last modified on
2014 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003272

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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