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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004500
Receipt No. R000004940
Scientific Title phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer
Date of disclosure of the study information 2010/11/02
Last modified on 2016/11/08

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Basic information
Public title phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer
Acronym phase 2 trial of panitumumab and irinotecan
Scientific Title phase 2 trial of panitumumab and irinotecan in previously oxaliplatin and irinotecan refractory patients with colorectal cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hirofumi Fujii
Organization Jichi Medical University
Division name Department of Clinical Oncology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498
TEL 0285-58-7546
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Nishi
Organization Tochigi Cancer Center
Division name Department of medical oncology
Zip code
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)

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 11 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.spandidos-publications.com/ol/11/6/4049/abstract
Number of participants that the trial has enrolled
Results
https://www.spandidos-publications.com/ol/11/6/4049/abstract
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
2010 Year 09 Month 11 Day
Date of IRB
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

Other
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

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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