UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003482
Receipt number R000004210
Scientific Title A Phase I /II Study of Tri-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.
Date of disclosure of the study information 2010/04/13
Last modified on 2014/02/05 17:43:22

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Basic information

Public title

A Phase I /II Study of Tri-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.

Acronym

BIX study

Scientific Title

A Phase I /II Study of Tri-weekly XELIRI with Bevacizumab for patient with Metastatic Colorectal Cancer as second-line chemotherapy.

Scientific Title:Acronym

BIX study

Region

Japan


Condition

Condition

colorectal cancer

Classification by specialty

Gastroenterology

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
Estimated the dose limiting toxicities in 1st cycle.
Phase II part
Progressiom 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

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)Histological confirmation of colorectal cancer.
(6) unresectable primary tumor or with one or more unresectable metatatic tumor
Measurable or evaluable disease
(measurable lesions in RECIST criteria is unnecessary)
(7) Progression during or after first-line chemotherapy for metastatic disease, including Oxaliplatin-based chemotherapy with bevacizumab
(8) Vital organ functions (listed below) are preserved within 2 weeks prior to entry
i. Neurtophils >= 1,500/mm3
ii. Platelets >= 100,000/mm3
iii. Hemoglobin >= 9.0g/dl
iv. Total bilirubin <= 1.5ml/dl
v. AST and ALT <= 100IU/l
(200IU/L in case of liver metastasis)
vi. Serum creatinine <= 1.5mg/dl
vii.Patients with UGT1A1 genotype wild type and *6,*28 heterozygote

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, 3+ 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

33


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhide Yamada

Organization

National Cancer Center Central hospital

Division name

Department of Gastroenterology

Zip code


Address

5-1-1tukiji Chuo-ku Tokyo, 104-0045

TEL

03-3542-2511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yasuhide Yamada/Takako nakajima

Organization

National Cancer Center Central hospital

Division name

Department of Gastroenterology

Zip code


Address

5-1-1tukiji Chuo-ku Tokyo, 104-0045

TEL

03-3542-2511

Homepage URL


Email



Sponsor or person

Institute

Epidemiological and Clinical research Information Network (ECRIN)

Institute

Department

Personal name



Funding Source

Organization

Epidemiological and Clinical research Information Network (ECRIN)

Organization

Division

Category of Funding Organization

Non profit foundation

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

2010 Year 04 Month 13 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 04 Month 22 Day

Date of IRB


Anticipated trial start date

2010 Year 05 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

2010 Year 04 Month 13 Day

Last modified on

2014 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004210


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name