UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer
Title of the study (Brief title)	phase 2 trial of panitumumab and irinotecan
Region	Japan

Condition
Condition	Colorectal Cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of panitumab and irinotecan for patients with K-ras wild, oxaliplatin and irinotecan refractory colorectal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	response rate
Key secondary outcomes	disease control rate, duration of response, progression free survival, overall survival, incidence of adverse events.

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	Patients receive panitumumab and irinotecan until progression.
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) unresectable or recurrent colorectal cancer histlogical proven 2)KRAS wild type in codon 12 and 13 in the primary or metastatic tumor tissue is confirmed 3) disease progression at the irinotecan containing chemotherapy or until 3 months from the last chemotherapy 4) fluorouracil refractory 5) oxaliplatin refractory 6) presence of at least one measurable lesion according to the RECIST 7) ECOG PS 0-2 8) No treatment duration after following treatment a) radiotherapy 2weeks b) organ resection 2weeks c) chemotherapy 2weeks d) hormone therapy 2weeks e) cytokine therapy, BRM 2weeks 9) patients have enough organ function for study treatment 1. neutrophil>=1,000/mm3 2. Platelet>=100,000/mm3 3. AST and ALT<=upper limit of normal (ULN)*3 (<=ULN*5 in case of liver metastasis) 4. Total bilirubin<=upper limit of normal (ULN)*3 5. Creatinin <=2.0mg/dL 10) Life expectancy of 8 weeks 11) written informed consent
Key exclusion criteria	1) symptomatic brain metastasis 2) waterly diarrhea 3) Paralytic or mechanical bowel obstruction 4) severe infectious disease 5) severe plumonary disease (interstitial lung disease or plumonary fibrosis) 6) severe complications (uncontrolable diabetes, heart failure NYHA>=III, renal failure, liver failure) 7) Pregnant or lactating women or women of childbearing potential 8) carcinomatosis meningitis 9) peripheral neuropathy Grade>=3 10)Need to treatment with flucytosine, atazanavir sulfate 11) history of Grade>=3 hypersensitivity due to monoclonal antibody therapy 12) history of Grade>=3 hypersensitivity due to irinotecan 13) history of treatment of anti EGFR pathway 14) patients judged inappropriate for this study by physicians
Target sample size	45

Research contact person
Name of lead principal investigator	Hirofumi Fujii
Organization	Jichi Medical University
Division name	Department of Clinical Oncology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498
TEL	0285-58-7546
Email

Public contact
Name of contact person	Tomohiro Nishi
Organization	Tochigi Cancer Center
Division name	Department of medical oncology
Address	4-9-13, Yohnan, Utsunomiya, Tochigi
TEL	028-658-5151
Homepage URL
Email

Sponsor
Institute	Jichi medical university
Institute
Department

Funding Source
Organization	Jichi medical university department of clinical oncology
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	2010 Year 11 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 11 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2012 Year 09 Month 01 Day
Date of closure to data entry	2013 Year 09 Month 01 Day
Date trial data considered complete	2013 Year 09 Month 30 Day
Date analysis concluded	2014 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.spandidos-publications.com/ol/11/6/4049/abstract
Results	https://www.spandidos-publications.com/ol/11/6/4049/abstract
Other related information

Management information
Registered date	2010 Year 11 Month 02 Day
Last modified on	2016 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004940