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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005228
Receipt No. R000006187
Scientific Title Phase II study of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab
Date of disclosure of the study information 2011/03/09
Last modified on 2016/03/09

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Basic information
Public title Phase II study of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab
Acronym Bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer
Scientific Title Phase II study of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and bevacizumab
Scientific Title:Acronym Bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safety of bevacizumab and irinotecan as second-line therapy in patients with metastatic colorectal cancer previously treated with fluoropyromidine, oxaliplatin, and bevacizumab
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Response Rate
Overall survival
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1) Bevacizumab 10mg/kg is administered by 10-30min. intravenous infusion, followed by irinotecan 150mg/m2 by 90 min infusion
(2)Patients should be received this chemotherapy biweekly until disease 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) Written informed consent
2) Age: 20 years old or older
3) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4) Histological confirmation of colorectal cancer
5) Life expectancy greater than or equal to 3 months
6)unresectable primary tumor or with one or more unresectable metastatic tumor
7)Measurable or evaluable disease (measurable lesions in RECIST ver1.1 criteria is unnecessary)
8)Progression during or after first line chemotherapy for metastatic disease, including Oxaliplatin based chemotherapy with bevacizumab(over 4 courses)
9)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery >=4 weeks. Radiation therapy >= 4weeks
10)Vital organ functions (listed below) are preserved within 2 weeks prior to entry
i) white blood >= 3000/mm3
ii) Neutrophils >= 1500/mm3
iii) Platelets >= 80000/mm3
iv) Hemoglobin >= 8.0 g/dl
v) Total bilirubin <= upper limit of normal (ULN) X 1.5
vi) AST and ALT <= ULMX2.5 (5XULM allowed in case of liver metastases)
vii) Serum creatinine <= ULM X 1.5mg/dl
viii) Protein urea <= 1+
Key exclusion criteria 1)Radiological evidence of CNS metastases or brain cancer
2)Complication of cerebrovascular disease or symptoms within 1 year
3) complication of GI perforation, or past history of perforation within 1 year
4) Uncontroled Gastrointestinal Ulcer
5) Uncontrolled Diarrhea
6) Receiving Atazanavir Sulfate
7)Paralytic or mechanical bowel obstruction
8) Evidence of bleeding diathesis or coagulopathy.
9) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS)
10) Clinically significant (i.e. active, CTCAEv4.0 >=Grade2) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
11) Uncontrolled Hypertension
12) Need to drain malignant coelomic fluid.
13) Evidence of interstinal lung disease, or pulmonary fibrosi
14) Uncontrolled infection
15) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers
16) History of the serious hypersensitivity for Fluorouracil or bevacizumab
17) Treatment history of irinotecan
18) 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 Kazuhiko Hayashi
Organization Tokyo Women's Medical University
Division name Department of chemotherapy and palliative care
Zip code
Address 8-1, Kawadacho, Shinjukuku, Tokyo, Japan
TEL 03-3353-8111
Email kuramochi@chemo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Kuramochi
Organization Tokyo Women's Medical University
Division name Department of chemotherapy and palliative care
Zip code
Address 8-1, Kawadacho, Shinjukuku, Tokyo
TEL 03-3353-8111
Homepage URL
Email kuramochi@chemo.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization None
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
2011 Year 03 Month 09 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 Completed
Date of protocol fixation
2011 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 11 Month 01 Day
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 09 Day
Last modified on
2016 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006187

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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