UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002761 |
|---|---|
| Receipt number | 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 17:16:01 |
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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
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
hqchemo@belle.shiga-med.ac.jp
Sponsor or person
Institute
NPO FMPC (Future Medicine Promoting
Consortium)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003272
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