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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007065
Receipt No. R000008071
Scientific Title Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab
Date of disclosure of the study information 2012/01/16
Last modified on 2012/02/10

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Basic information
Public title Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab
Acronym Bevacizumab Beyond Progression Plus Irinotecan trial
Scientific Title Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab
Scientific Title:Acronym Bevacizumab Beyond Progression Plus Irinotecan trial
Region
Japan

Condition
Condition advanced colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of bevacizumab and irinotecan as second-line therapy patients with advanced colorectal cancer previously treated with fluoropyrimidine,oxaliplatin,and bevacizumab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Progression free survival
Key secondary outcomes Overall survival
Response Rate
Progression free survival according to K-ras status
Overall survival according to K-ras status
Frequency 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 Bevacizumab+Irinotecan
Bevacizumab: 10mg/kg d.i.v. day1
Irinotecan:150mg/m2 d.i.v.day1
to be repeated every 2 weeks
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)Disease progression after chemotherapy with bevacizumab as 1st-Line Oxaliplatin containing regimen
(2)Oxaliplatin and bevacizumab were administrated for more than 4 times in 1st-Line
(3)Difficult to continue 5FU treatment
(4)Colorectal cancer,cytologically and/or histrogically
(5)Written informed consents
(6)Age:20 years old and above
(7)Eastern Cooperative Oncology Group (ECOG) perormance status 0-2
(8)Life expectancy estimated over 3 months
(9)Sufficient organ functions

Key exclusion criteria (1)Previously irinotecan treatment
(2)Administering transfusion/hematopoietic factor or antithrombotic drug within 14 days
(3)Serious renal dysfunction
(4)Serious drug hypersensitivity or a history of drug allergy
(5)Active concomitant malignancy
(6)Uncontrolled infection
(7)Symptomatic or asymptomatic but treated heart disease
(8)History of thrombosis,interstitial pneumonitis,pulmonary fibrosis or high-grade pulmonary emphysema
(9)Fresh hemorrhage from digestive tube,intestines tube paralysis,intestinal obstruction and peptic ulcer
(10)Pleural effusion,peritoneal fluid and pericardial fluid
(11)Symptomatic brain metastasis
(12)History of mental disturbances or cerebrovascular accident
(13)high blood pressure and diabetic that cannot be controlled
(14)Uncontrolled diarrhea
(15)Serious non-healing wound and/or major surgical procedure within 4weeks prior to enroll in this study
(16)Traumatic fracture of unrecovery
(17)Bleeding tendency and anti-platelets therapy
(18)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers
(19)Need to treatment with atazanavir sulfate
(20)Paralyzed bowel
(21)Other conditions not suitable for this study
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Hirai
Organization Toyama Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address 2-2-78 Nishinagae,Toyama-shi,Toyama-ken
TEL 076-424-1531
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Toyama Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Email sh915@bc5.so-net.ne.jp

Sponsor
Institute Toyama Prefectural Central Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization Toyama Prefectural Central Hospital Department of Gastroenterology
Organization
Division
Category of Funding Organization Local Government
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
2012 Year 01 Month 16 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
2011 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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
2012 Year 01 Month 13 Day
Last modified on
2012 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008071

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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