UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005991
Receipt number R000007089
Scientific Title A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.
Date of disclosure of the study information 2011/07/20
Last modified on 2011/07/17 22:41:10

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Basic information

Public title

A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.

Acronym

A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.

Scientific Title

A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.

Scientific Title:Acronym

A Phase II study of Pemetrexed plus Carboplatin Plus Bevacizumab followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or non-squamous non-small-cell and lung cancer.

Region

Japan


Condition

Condition

Non-squamous non-small cell lung cancer (EGFR mutation status Negative)

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate the efficacy and safety of Pemetrexed plus Carboplat plus Bevacizumab in followed by maintenance Pemetrexed in patients with previously untreated stage III/IV non-squamous non-small-cell and lung cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

RR: Response rate

Key secondary outcomes

QOL: Quality of life
DCR: Disease control rate
PFS: Progression free Survival
OS: Overall survival
AE: Adverse events


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

Four cycles of Pemetrexed + Carboplatin + Bevacizumab followed by maintenance Pemetrexed 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer.(EGFR mutation status negative).
2)Stage III/IV unresectable or unsuitable for radical irradiation Non-Squamous NSCLC.
3)No prior chemotherapy .
4)Measurable tumor sites
5)ECOG-PS of 0 or 1.
6)20years-old,more than 80years-old
7)No prior systemic anticancer therapy including palliative brain or bone irradiation within 2 weeks of proposed entry to this trial.
8)Life expectancy more than 3 months.
9)No problem adequate organ function
10) Written informed consent from the patients.

Key exclusion criteria

1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan.
2)Patients with active co-morbidities including severe conditions.
1.uncontrollable angina pectoris, myocardial infarction within 3 months, severe heart disease.
2.uncontrollable diabetes, hypertension.
3.severe infection
4.paresis of intestine, illeus
5.Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum
6.Great vessel involvement
7.Melena
8.Receiving anticoagulant drug
9.Uncontrolled urinari protein
10.CongenitalbleedingdiathesisCoagulation abnormalities
11.Patients whose participation in the trial is judged to be inappropriate by the attending doctor.
3)Patients with massive pleural and cardiac effusion and ascites that need to be immediately treated.
4) Brain metastases with neurological symptoms.
5) Active double cancer.
6)Pregnancy, breast feeding and suspected pregnancy.
7)History of grave drug allergic reaction.
8) Psychiatric disorder.
9) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor.

Target sample size

35


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazutoshi Isobe

Organization

Toho University Omori Medical Center

Division name

respiratory medicine

Zip code


Address

6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan

TEL

03-3762-4151

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazutoshi Isobe

Organization

Toho University Omori Medical Center

Division name

respiratory medicine

Zip code


Address

6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan

TEL

03-3762-4151

Homepage URL


Email

kazutoshiisobe@aol.com


Sponsor or person

Institute

Toho University Omori Medical Center

Institute

Department

Personal name



Funding Source

Organization

Non

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

2011 Year 07 Month 20 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

Open public recruiting

Date of protocol fixation

2011 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 08 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

2011 Year 07 Month 17 Day

Last modified on

2011 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007089


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name