UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II crinical trial of cetuximab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer
Title of the study (Brief title)	Cetuximab Rechallenge
Region	Japan

Condition
Condition	Colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	This phase II prospective study aims to investigate the activity of a retreatment with a cetuximab-based therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate(RR)
Key secondary outcomes	Progression free survival(PFS) Overall survival(OS) Safety

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	This is a multicentric phase II trial that examines patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab- plus FOLFOX/FOLFIRI therapy and then a progression of disease, during cetuximab-based therapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another Cetuximab based chemotherapy.
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)Histopathological confirmation of Adenocarcinoma 2EGFR expression confirmed by immunohistochemistry either in the primary tumor or in metastatic tumor lesion 3)KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion 4)Patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab based chemotherapy and then a progression of disease or intolerable of adverse events, during cetuximab based chemotherapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another cetuximab chemotherapy. 5)Age of 20 or more years old 6)ECOG performance status of 0 to 2 7)Presence of at least one measurable lesion according to RECIST 8)Sufficient function of important organs 1. WBC:>= 2,000 /mm3 2. Neu: >= 1,500 /mm3 3. Platelet: >= 75,000 /mm3 4. Hemoglobin: >= 8.0 g/dL 5. Sr.bil : <= 2.5 mg/dL 6. AST, ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST, ALT : <= ULNx5.0) 7. Serum creatinine: <= ULNx1.5 9)Expected more than 3 months survival 10)With written informed consent
Key exclusion criteria	1)Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ 2)Patients with brain metastasis which have symptoms or patients with history of brain metastasis 3)Severe wattery diarrhea 4)Severe infectious disease 5)Severe complications (interstitial lung disease or pulmonary fibrosis, kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension) 6)Severe carcinomatous ascites, pleural effusion or pericardial cavity effusion 7)Pregnant or lactating women or women of childbearing potential, and no birth-control 8)Patients with history of serious hypersensitivity
Target sample size	25

Research contact person
Name of lead principal investigator	Toshiyoshi Fujiwara
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7257
Email

Public contact
Name of contact person	Takeshi Nagasaka
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7257
Homepage URL
Email

Sponsor
Institute	Okayama Molecular Target-Based Drugs Society for Cancer of the Colon and Rectum
Institute
Department

Funding Source
Organization	Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 01 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 12 Month 19 Day
Anticipated trial start date	2013 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 05 Day
Last modified on	2018 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011370