UMIN-CTR Clinical Trial

Public title

Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab

Acronym

Bevacizumab Beyond Progression Plus Irinotecan trial

Scientific Title

Phase 2 study of bevacizumab and irinotecan as second-line therapy in patients with advanced colorectal cancer previously treated with oxaliplatin and bavacizumab

Scientific Title:Acronym

Bevacizumab Beyond Progression Plus Irinotecan trial

Region

Japan

Condition

advanced colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness and safety of bevacizumab and irinotecan as second-line therapy patients with advanced colorectal cancer previously treated with fluoropyrimidine,oxaliplatin,and bevacizumab

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Progression free survival

Key secondary outcomes

Overall survival
Response Rate
Progression free survival according to K-ras status
Overall survival according to K-ras status
Frequency of adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bevacizumab+Irinotecan
Bevacizumab: 10mg/kg d.i.v. day1
Irinotecan:150mg/m2 d.i.v.day1
to be repeated every 2 weeks

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Disease progression after chemotherapy with bevacizumab as 1st-Line Oxaliplatin containing regimen
(2)Oxaliplatin and bevacizumab were administrated for more than 4 times in 1st-Line
(3)Difficult to continue 5FU treatment
(4)Colorectal cancer,cytologically and/or histrogically
(5)Written informed consents
(6)Age:20 years old and above
(7)Eastern Cooperative Oncology Group (ECOG) perormance status 0-2
(8)Life expectancy estimated over 3 months
(9)Sufficient organ functions

Key exclusion criteria

(1)Previously irinotecan treatment
(2)Administering transfusion/hematopoietic factor or antithrombotic drug within 14 days
(3)Serious renal dysfunction
(4)Serious drug hypersensitivity or a history of drug allergy
(5)Active concomitant malignancy
(6)Uncontrolled infection
(7)Symptomatic or asymptomatic but treated heart disease
(8)History of thrombosis,interstitial pneumonitis,pulmonary fibrosis or high-grade pulmonary emphysema
(9)Fresh hemorrhage from digestive tube,intestines tube paralysis,intestinal obstruction and peptic ulcer
(10)Pleural effusion,peritoneal fluid and pericardial fluid
(11)Symptomatic brain metastasis
(12)History of mental disturbances or cerebrovascular accident
(13)high blood pressure and diabetic that cannot be controlled
(14)Uncontrolled diarrhea
(15)Serious non-healing wound and/or major surgical procedure within 4weeks prior to enroll in this study
(16)Traumatic fracture of unrecovery
(17)Bleeding tendency and anti-platelets therapy
(18)Pregnant women,possibly pregnant women,wishing to become pregnant,and nursing mothers
(19)Need to treatment with atazanavir sulfate
(20)Paralyzed bowel
(21)Other conditions not suitable for this study

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Hirai

Organization

Toyama Prefectural Central Hospital

Division name

Department of Gastroenterology

Zip code

Address

2-2-78 Nishinagae,Toyama-shi,Toyama-ken

TEL

076-424-1531

Email

Name of contact person

1st name
Middle name
Last name

Organization

Toyama Prefectural Central Hospital

Division name

Department of Gastroenterology

Zip code

Address

TEL

Homepage URL

Email

sh915@bc5.so-net.ne.jp

Institute

Toyama Prefectural Central Hospital Department of Gastroenterology

Institute

Department

Personal name

Organization

Toyama Prefectural Central Hospital Department of Gastroenterology

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

01

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2011

Year

11

Month

25

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

01

Month

13

Day

Last modified on

2012

Year

02

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008071