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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003288
Receipt No. 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

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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
Email 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
Email makiyama.a@qkn-hosp.jp

Sponsor
Institute Kyushu Medical Oncology Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003977

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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