UMIN-CTR Clinical Trial

Public title

A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer

Acronym

A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer

Scientific Title

A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer

Scientific Title:Acronym

A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer

Region

Japan

Condition

elderly patients with stage IIIB/IV non-small cell lung cancer except for squamous cell carcinoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of pemetrexed/bevacizumab in elderly patients with advanced Non-squamous Non-smallcell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

response rate

Key secondary outcomes

disease control rate, progression free survival, overall survival, safety,
evaluavte effectiveness by tumor maker(CYFRA)

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

Pemetrexed(500mg/m2) and bevacizumab(15mg/kg) will be administered triweekly until disease progression.

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

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) histologically confirmed non-small cell lung cancer except for squamous cell carcinoma

2) chemotherapy naive

3) clinical stage IIIB/IV or relapsed case

4) with measurable lesions

5) written informed consent after the explanation of the content of the examination

6) more than 75-years old

7) PS (ECOG) 0-2

8) estimated survival is more than 3 months

9) Adequate organ functions
Neutrophil: => 1500 /mm3
Platelet: => 100,000 /mm3
Hemoglobin concentration: => 9.0 g/dl
Total bilirubin: <= 1.5 mg/dl
AST or ALT: <= 100IU/l
Cr: <= 1.2 mg/dl
proteinuria: <= 1+

Key exclusion criteria

1) transfusion or G-CSF within 2weeks prior to enrollment

2) history of severe drug allergy

3) history of active double cancer within 5 years

4) history of active severe infections

5) severe cardiac disease

6) history of thromboembolism or severe pulmonary disease

7) history of GI bleeding, ileus, GI ulceration

8) history of hemoptysis (more than 2.5mL)

9) massive pleural or pericardial effusion, ascites

10) active brain metastases

11) history of mental disorder, central nervous system damage, cerebrovascular disease

12) Uncontrollable hypertension or diabetes mellitus

13)Uncontrollable diarrhea

14)Wound of unrecovery

15)bleeding diathesis or receiving anticoagulant drug(except Aspirin under 324mg/day)

16)Evaluated to be ineligible by a physician for other reasons

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Keisuke Aoe

Organization

Yamaguchi-Ube Medical Center

Division name

Department of Medical Oncology

Zip code

Address

685, Higasikiwa Ube, Yamaguchi

TEL

0836-58-2300

Email

aoe@yamaguchi-hosp.jp

Name of contact person

1st name
Middle name
Last name	Keisuke Aoe

Organization

Yamaguchi-Ube Medical Center

Division name

Department of Medical Oncology

Zip code

Address

685 Higashikiwa, Ube, Yamaguchi

TEL

0836-58-2300

Homepage URL

Email

maeda@yamaguchi-hosp.jp

Institute

Yamaguchi Thoracic Oncology Group (YTOG)

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

山口大学医学部附属病院、徳山中央病院、長門総合病院、済生会下関総合病院、山口県立総合医療センター、下関市立市民病院、関門医療センター、岩国医療センター、済生会山口総合病院、山口宇部医療センター

Date of disclosure of the study information

2012

Year

11

Month

01

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

2012

Year

09

Month

25

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

01

Day

Last follow-up date

2016

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

10

Month

16

Day

Last modified on

2016

Year

10

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010702