UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001668 |
|---|---|
| Receipt number | R000001978 |
| Scientific Title | Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on KRAS mutation status (T-CORE0801) |
| Date of disclosure of the study information | 2009/01/31 |
| Last modified on | 2015/07/29 22:20:03 |
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Basic information
Public title
Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on KRAS mutation status (T-CORE0801)
Acronym
Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-resisitant advanced and/or metastatic colorectal cancer with KRAS mutation analysis (T-CORE0801)
Scientific Title
Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-refractory patients with EGFR-positive advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on KRAS mutation status (T-CORE0801)
Scientific Title:Acronym
Phase II trial of cetuximab plus irinotecan for FOLFOX and FOLFIRI-resisitant advanced and/or metastatic colorectal cancer with KRAS mutation analysis (T-CORE0801)
Region
| Japan |
Condition
Condition
3rd line or later therapy for unresectable advanced and/or recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We confirm safety and efficacy of cetuximab plus irinotecan as a 3rd line or later therapy in patients with EGFR positive unresectable advanced and/or recurrenct colorectal cancer. We also examine KRAS mutation as a prospective analysis and compare the safety and efficacy of cetuximab plus irinotecan between KRAS wild-type and mutant group. As an accompanied study, we further examine mutations in BRAF, PIK3CA and PTEN, microsatellite instability, and two SNPs in Fcgamma receptor genes (FcgammaRIIa-H131R and FcgammmaRIIIa-V158F) and compare the safety and efficacy of cetuximab plus irinotecan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
progression free survival (PFS), overall survival(OS) and safety
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
cetuximab 400 mg/m2 given as 2 hours infusion for the first time, 250mg/m2 as 1 hour infusion for the second time or later. Irinotecan 100mg/m2 repeated every week followed by one week rest or Irinotecan 150mg/m2 repeated every two weeks.
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
The criteria for eligibility were histologically proven EGFR positive colorectal cancer of; an age of 20 or older; with an unresectable primary tumor or with one or more unresectable metatatic tumor(s); more than two privious treatment by FOLFOX or FOLFIRI regimen; with performance status (ECOG) 0, 1 or 2; the following interval from previous treatments (4 weeks from radiations, 2weeks from a operation with some organ resection, 2 weeks from chemotherapy, 4 weeks from other clinical trial), measurable lesions based on the RECIST; and adequate organ function (a neutrophil count of 1500 or more per cubic millimeter ; a platelet count of at least 100,000 per cubic millimeter; hemoglobin levels of more than 8.0 g per deciliter ;aspartate
aminotransferase and alanine aminotransferase levels of 100 or less international unit per litter; a total bilirubin level of no more than 2.0 mg per deciliter; and a serum creatinine
level of no more than 1.5 mg per deciliter; expected more than 2 months prognosis; with a written informed consent for this study
Key exclusion criteria
The exclusion criteria were symptomatic metastatic brain tumor, uncontrolled massive pleural or abdominal effusion, previous meningitis carcinomatosis, uncontrolled epilepsy, critical mental disturbance, central nervous system disorder, uncontrolled diabtes mellitus, uncontrolled hypertension, active infection treated with antibiotics, antifungal or antiviral drugs, bleeding tendency, symptomatic coagulation abnormality, acute pneumonia, interstitial pneumonitis or pulmonary fibrosis, chronic disease required the treatment with steroid or immune-suppressing drug, diarrhea; with complication of paralytic intestine, bowel obstraction (ileus), previous history of herpersensitivity (Grade 3 or severe) against monoclonal antibody drug, previous history of herpersensitivity against irinotecan, pevious therapy with inhibitor of EGF signal transduction or inhibitor of EGFR, treated with Atazanavir Sulfate, active double cancer within 5 years, Grade 3 or severe neural disturbance, Grade III or IV by NYHA classification or sever cardiac disease within 6 months.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Shimodaira |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Clinical Oncology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-7171-8547
hshimoda@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kato |
Organization
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Division name
Office
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-8599
Homepage URL
http://www.T-CORE.JP
t-core-admin@umin.ac.jp
Sponsor or person
Institute
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
Institute
Department
Personal name
Funding Source
Organization
NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
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 | 01 | Month | 31 | Day |
Related information
URL releasing protocol
http://www.t-core.jp
Publication of results
Published
Result
URL related to results and publications
http://www.karger.com/Article/FullText/360989
Number of participants that the trial has enrolled
Results
Results:KRAS mutations were detected in 31.7% of 41 eligible patients. The RR to cetuximab plus irinotecan therapy was found to be 17.9 and 0% in the KRAS wild-type and mutant subgroups, respectively. Conclusion: Despite the identification of a lower-than-expected RR to treatment by the KRAS wild-type subgroup, KRAS mutation status appears to be a useful predictive marker of response to cetuximab plus irinotecan therapy in Japanese mCRC patients.
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 | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
As a prospective study, mutation analysis of KRAS, BRAF, PIK3CA, and PTEN genes, microsatellite instability (MSI) and two common SNPs of Fc gamma receptor genes will be examined for all enrolled patients
Management information
Registered date
| 2009 | Year | 01 | Month | 29 | Day |
Last modified on
| 2015 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001978
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