UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003288 |
|---|---|
| Receipt number | R000003977 |
| Scientific Title | Phase I/II study of Cetuximab combined with S-1 and irrinotecan (CeIRIS) in KRAS wild type metastatic colorectal cancer patients refractory to treatment with oxaliplatin and fluoropyrimidine. |
| Date of disclosure of the study information | 2010/03/04 |
| Last modified on | 2014/09/04 11:58:06 |
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Basic information
Public title
Phase I/II study of Cetuximab combined with S-1 and irrinotecan (CeIRIS) in KRAS wild type metastatic colorectal cancer patients refractory to treatment with oxaliplatin and fluoropyrimidine.
Acronym
KMOG0901 CeIRIS trial
Scientific Title
Phase I/II study of Cetuximab combined with S-1 and irrinotecan (CeIRIS) in KRAS wild type metastatic colorectal cancer patients refractory to treatment with oxaliplatin and fluoropyrimidine.
Scientific Title:Acronym
KMOG0901 CeIRIS trial
Region
| Japan |
Condition
Condition
Colorectal cancer: KRAS wild type
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 combined with S-1 and irrinotecan (CeIRIS) in KRAS wild type metastatic colorectal cancer patients refractory to treatment with oxaliplatin and fluoropyrimidine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) Phase I study
To determine the maximum tolerated dose (MTD) and recommended dose (RD)
2) Phase II study
Response rate
Key secondary outcomes
1) Phase I study
To evaluate the toxicity and efficacy
2) Phase II study
Progression-free survival, Overall survival, Disease control rate, Time to treatment failure and Safety profile
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cetuximab: Weekly administration 400 mg/m2 for the 1st time (day1), 250mg/m2/week for the 2nd time or another (day8,15,..)
TS-1 is orally administered b.i.d. on days 1-14 and CPT-11 is intravenously administered on days 1 and 8 every 3 weeks
S-1:Level1 65mg/m2 day1-14
Level2 80mg/m2 day1-14
CPT-11:Level1,2 80mg/m2, day1,8
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
1) Histologically proven colorectal cancer
2) KRAS WT unresectable advanced/recurrent colorectal cancer
3) Confirmed UGT1A1 genotype: both *6 and *28 wild type, or either *6 or *28 heterozygote type
4) Presence of measurable lesion
5) Age >=20 and =<75
6) Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1
7) Patients who had documented progressive disease after a minimum of 4 weeks of oxaliplatin and fluoropyrimidine containing chemotherapy.
8) No prior chemotherapy involving TS-1 or CPT-11 or Cetuximab.
9) Previous chemotherapy completed at least 2 weeks before inclusion.
10) Ability of oral intake
11) Submission of the available microsection (5-10um, more than 3 cut slides) to perform genetic test for KRAS and BRAF and microscopic test with hematoxylin-eosin stain.
12) With normal function of the important organs
13) Life expectancy of more than 3 months
14) With a written informed consent
15) Adequate organ function, evidenced by the following laboratory results within 1 week prior to registration.
1. WBC 3,000/mm3-12,000/mm3
2. Neurtophils >=1,500/mm3
3. Platelets >=100,000/mm3
4. Hemoglobin >=9.0g/dl
5. AST and ALT <=100IU/l
6. Total bilirubin <=1.5mg/dl
7. Creatinine <1.5mg/dl
Key exclusion criteria
1) Severe comorbidity (active infectious disease, severe cerebrovascular disorder, uncontrolable diabetes, heart failure, angina, myocardial infarction within three months, severe hepatic disorder, jaundice etc)
2) Comorbidity or history of interstitial lung disease or pulmonary fibrosis
3) Massive pleural effusion or ascites
4) Symptomatic brain metastasis
5) Wattery diarrhea
6) Paralytic or mechanical bowel obstruction
7) Patients who is receiving Fluorocytosine
8) Patients who is receiving Atazanavir Sulfate
9) Simultaneous or metachronous double cancers
10) History of severe allergy
11) Current chronic daily treatment with corticosteroids(oral intake or intravenously)
12) Severe infectious disease
13) Amalgamation of mental disease or psychotic manifestation
14) Pregnant or lactating women or women of childbearing potential.
15) Any other patient whom the physician in charge of the study judges to be unsuitable.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | T. Esaki |
Organization
National Kyushu Cancer Center
Division name
Gastrointestinal and Medical Oncology Division
Zip code
Address
3-1-1 Notame, Minami-ku, Fukuoka-city, Fukuoka, 811-1395, JAPAN
TEL
092-541-3231
tesaki@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | A. Makiyama |
Organization
JCHO Kyushu Hospital
Division name
Department of Hematology/Oncology
Zip code
Address
1-8-1 kishinoura, yahatanishi-ku, Kitakyushu, Fukuoka 806-8501, Japan
TEL
093-641-5111
Homepage URL
makiyama.a@qkn-hosp.jp
Sponsor or person
Institute
Kyushu Medical Oncology Group
Institute
Department
Personal name
Funding Source
Organization
HO
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Medical Oncology, First Department of Internal Medicine, Faculty of Medicine, Kyushu University
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
| 2010 | Year | 03 | Month | 04 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | 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
| 2010 | Year | 03 | Month | 04 | Day |
Last modified on
| 2014 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003977
