UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003990 |
|---|---|
| Receipt number | 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 10:52:00 |
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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
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
m.suenaga@jfcr.or.jp
Sponsor or person
Institute
Japanese foundation for cancer research
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004805
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