UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009911
Receipt number R000011613
Scientific Title A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.
Date of disclosure of the study information 2013/01/30
Last modified on 2018/08/14 01:16:16

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Basic information

Public title

A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.

Acronym

A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.

Scientific Title

A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.

Scientific Title:Acronym

A phaseI/II study of irinotecan with bevacizumab as second line treatment of elderly patients with metastatic colorectal cancer.

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 second-line chemotherapy in the patients aged 70 and over with unresectable advanced recurrent coloreatal cancer previously treated with Bevacizumab + fluorinated pyrimidine +/- L-OHP.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Phase I part
Estimated the dose limiting toxicities in 1st cycle.
Phase II part
Progression Free Survival

Key secondary outcomes

Safety
overall 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

70 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1)Written informed consent.
(2)Age and Eastern Cooperative Oncology Group (ECOG) performance status (PS) :
I.70-74:PS2
II.75<= : PS0-2
(3)Life expectancy greater than or equal to 3 months.
(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 during or after first-line chemotherapy for metastatic disease, including bevacizumab with 5FU +/- L-OHP.
(8)Vital organ functions (listed below) are preserved within 2 weeks prior to entry.
I.Leukocyte count >=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 <=2.0mg/dl
VII.Serum creatinine <=1.2mg/dl
VIII.Patients with UGT1A1 genotype wild type and *6,*28 heterozygote

Key exclusion criteria

(1)Need to drain malignant celomic fluid.
(2)Jaundice
(3)Paralytic or mechanical bowel obstruction.
(4)Receiving Atazanavir Sulfate
(5)Radiological evidence of CNS metastases or brain cancer.
(6)Multiple primary cancers within 5 years.
(7)Complication of cerebrovascular disease or symptoms within 1 year.
(8)Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week.
(9)Administering antithrombotic drug within 10 days.
(10)Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS).
(11)Evidence of bleeding diathesis or coagulopathy.
(12)Active gastrointestinal ulcer
(13)Current or previous (within the last 1 year) history of GI perforation.
(14)Non healing fracture
(15)Renal failure to be treated,3+ or higher proteinuria within 2 weeks prior to entry.
(16)Uncontrolled Hypertension
(17)Uncontrolled diabetes mellitus
(18)Clinically significant (i.e. active) cardiovascular disease or past or current history (within the last 1 year) of myocardial infarction.
(19)History of the serious hypersensitivity for bevacizumab.
(20)Evidence of interstinal lung disease, or pulmonary fibrosis.
(21)History of organ transplantation.
(22)Treatment history of irinotecan.
(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 or person

Institute

Tsuchiura kyodo general hospital

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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011613


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name