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Recruitment status Terminated
Unique ID issued by UMIN UMIN000009910
Receipt No. R000011612
Scientific Title A phaseII study of irinotecan with bevacizumab as third line treatment for patients with metastatic colorectal cancer after failure to irinotecan who have progressed on bevacizumab with oxaliplatin-based chemotherapy in second line.
Date of disclosure of the study information 2013/01/30
Last modified on 2018/08/14

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Basic information
Public title A phaseII study of irinotecan with bevacizumab as third line treatment for patients with metastatic colorectal cancer after failure to irinotecan who have progressed on bevacizumab with oxaliplatin-based chemotherapy in second line.
Acronym A phaseII study of irinotecan with bevacizumab as third line treatment for patients with metastatic colorectal cancer after failure to irinotecan who have progressed on bevacizumab with oxaliplatin-based chemotherapy in second line.
Scientific Title A phaseII study of irinotecan with bevacizumab as third line treatment for patients with metastatic colorectal cancer after failure to irinotecan who have progressed on bevacizumab with oxaliplatin-based chemotherapy in second line.
Scientific Title:Acronym A phaseII study of irinotecan with bevacizumab as third line treatment for patients with metastatic colorectal cancer after failure to irinotecan who have progressed on bevacizumab with oxaliplatin-based chemotherapy in second line.
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 and safety of the combination of Irinotecan + Bevacizumab as third-line chemotherapy in the patients with unresectable advanced recurrent coloreatal cancer previously treated with Bevacizumab + fluorinated pyrimidine + L-OHP after failure to irinotecan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes Safety
Overall Survival
Total Survival
Overall Response Rate
Disease Control Rate

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 Irinotecan + Bevacizumab
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
3.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
4.Histological confirmation of colorectal cancer.
5.Advanced or recurrent colorectal cancer that is not amenable to curative resection.
6.Measurable or evaluable disease.
7.Progression after first-line chemotherapy for metastatic disease, including bevacizumab or anti-EGFR monoclonal antibody with irinotecan.
8.Patients who had a clinical benefit (confirmed stable disease (SD) for at least 6 months or clinical response) in primary treatment with irinotecan.
9.Progression during or after second-line chemotherapy for metastatic disease, including bevacizumab with fluorinated pyrimidine + L-OHP.( In the case of side effects, the treatment by bevacizumab + fluorinated pyrimidine after stopping L-OHP is continuable.)
10.Less than 75mg/m2/week irinotecan in primary treatment was administered.(in the case of the FOLFIRI regimen the dosage of irinotecan was decreased by the start of the 3rd cycle)
11.Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
I.Leukocyte >=3,000/mm3
II.Neurtophils >=1,500/mm3
III.Platelets >=100,000/mm3
IV.Hemoglobin >=9.0g/dl
V.AST and ALT <= 100IU/l
(200IU/l in case of liver metastasis)
VI.Total bilirubin <= 2.0ml/dl
VII.Serum creatinine <= 1.2mg/dl
Key exclusion criteria (1) Need to drain malignant celomic fluid.
(2)Radiological evidence of CNS metastases or brain cancer.
(3) Multiple primary cancers within 5 years.
(4) Complication of cerebrovascular disease or symptoms within 1 year.
(5)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
(6) The patient who is planning the surgical treatment during trial.
(7)Administering antithrombotic drug within 10 days.
(8)Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS).
(9) Evidence of bleeding diathesis or coagulopathy.
(10)Active gastrointestinal ulcer
(11)Current or previous (within the last 1 year) history of GI perforation.
(12)Non healing fracture
(13)Renal failure to be treated,3+ or higher proteinuria within 2 weeks prior to entry.
(14)Uncontrolled Hypertension
(15)Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction.
(16)History of the serious hypersensitivity for irinotecan or bevacizumab.
(17)Uncontrolled diarrhea
(18)Evidence of interstinal lung disease, or pulmonary fibrosis.
(19)History of organ transplantation.
(20)Uncontrolled infection
(21)Pregnant or lactating women or women of childbearing potential.
(22) Men without the intention of preventing conception.
(23) Other conditions not suitable for this study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshinori Sakai
Organization Tsuchiura kyodo general hospital
Division name Department of Gastroenterology
Zip code
Address 11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Masuishi
Organization Tsuchiura kyodo general hospital
Division name Department of Gastroenterology
Zip code
Address 11-7 Manabeshinmachi, Tsuchiura, Ibaraki, Japan
TEL
Homepage URL
Email

Sponsor
Institute Tsuchiura kyodo general hospital
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
2013 Year 01 Month 30 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 Terminated
Date of protocol fixation
2013 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 02 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
2013 Year 01 Month 30 Day
Last modified on
2018 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011612

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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