UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019893 |
|---|---|
| Receipt number | 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 15:30:45 |
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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
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
eiji.shinozaki@jfcr.or.jp
Sponsor or person
Institute
The Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022856
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
