UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007065 |
|---|---|
| Receipt number | 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 16:51:57 |
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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
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
sh915@bc5.so-net.ne.jp
Sponsor or person
Institute
Toyama Prefectural Central Hospital Department of Gastroenterology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008071
