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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003990
Receipt No. R000004805
Scientific Title A Phase I /II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.
Date of disclosure of the study information 2010/08/25
Last modified on 2016/02/16

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Basic information
Public title A Phase I /II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.
Acronym BIXER study
Scientific Title A Phase I /II Study of Bi-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.
Scientific Title:Acronym BIXER study
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 safety and efficacy of XELIRI and bevacizumab in patients with metastatic colorectal cancer who have first-line chemotherapy including treatment failure or refractory.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I part
To determine Safety in 1st cycle by Bi-weekly XELIRI+bevacizumab.
Phase II part
Progression Free Survival
Key secondary outcomes Phase II
Safety
response 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 XELIRI+ bevacizumab
Capecitabine:2000mg/m2/day d1-8
Irinotecan:180mg/m2 d1
Bevacizumab:5mg/kg d1
Q2w
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Written informed consent
2) Age: 20-75 years old.
3)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
4) Life expectancy greater than or equal to 3 months
5) Confirmed wild or hetero of UGT1A1*6*28 genotype.
6)Histological confirmation of colorectal cancer.
7) Unresectable primary tumor or with one or more unresectable metatatic tumor
Measurable or evaluable disease
(measurable lesions in RECIST criteria is unnecessary)
8) Progression during or after first-line chemotherapy for metastatic disease, including Oxaliplatin-based chemotherapy with bevacizumab
9) Vital organ functions (listed below) are preserved within 2 weeks prior to entry
i. Neurtophils>=2000/mm3
ii. Platelets>=100,000/mm3
iii. Hemoglobin>=9.0g/dl
iv. Total bilirubin>=upper limit of normal (ULN)*1.5
v. AST and ALT<=upper limit of normal (ULN)*2.5
(<=ULN*5 in case of liver metastasis)
vi. Serum creatinine<=upper limit of normal (ULN)*1.5
Key exclusion criteria (1) Treatment with tegafur gimestat otastat potassium within 7 days
(2) Need to drain malignant coelomic fluid.
(3) Jaundice
(4) Paralytic or mechanical bowel obstruction
(5) Receiving Atazanavir Sulfate
(6) Radiological evidence of CNS metastases or brain cancer
(7) Multiple primary cancer within 5 years.
(8) Complication of cerebrovascular disease or symptoms within 1 year.
(9) Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
(10) Administering antithrombotic drug within 10 days.
(11) Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS)
(12) Evidence of bleeding diathesis or coagulopathy.
(13) Active gastrointestinal ulcer
(14) Current or previous (within the last 1 year) history of GI perforation
(15) Non healing fracture
(16) Renal failure to be treated, 2+ or higher proteinuria within 2 weeks prior to entry
(17)Uncontrolled Hypertension
(18) Uncontrolled diabetes mellitus
(19) Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction
(20) History of the serious hypersensitivity for Fluorouracil or bevacizumab
(21) Evidence of interstinal lung disease, or pulmonary fibrosis
(22) History of organ transplantation
(23) Treatment history of irinotecan
(24) Other conditions not suitable for this study
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Mizunuma
Organization The cancer institute hospital of JFCR
Division name Gastroenterological center
Zip code
Address 3-8-31 Ariake, Kotou-ku, Tokyo
TEL 03-3520-0111
Email mizunuma@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Matsusaka, Mitsukuni Suenaga
Organization The cancer institute hospital of JFCR
Division name Gastroenterological center
Zip code
Address 3-8-31 Ariake, Kotou-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email m.suenaga@jfcr.or.jp

Sponsor
Institute Japanese foundation for cancer research
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 癌研究会有明病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2014 Year 08 Month 07 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 11 Month 26 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 03 Day
Last modified on
2016 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004805

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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