UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005228 |
|---|---|
| Receipt number | 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 11:19:56 |
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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
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
kuramochi@chemo.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006187
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