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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003680
Receipt No. R000004461
Scientific Title Phase II study of Pemetrexed and Carboplatin plus Bevacizumab for advanced non-small cell lung cancer
Date of disclosure of the study information 2010/06/03
Last modified on 2013/05/31

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Basic information
Public title Phase II study of Pemetrexed and Carboplatin plus Bevacizumab for advanced non-small cell lung cancer
Acronym Phase II study of Pemetrexed and Carboplatin plus Bevacizumab for advanced non-small cell lung cancer
Scientific Title Phase II study of Pemetrexed and Carboplatin plus Bevacizumab for advanced non-small cell lung cancer
Scientific Title:Acronym Phase II study of Pemetrexed and Carboplatin plus Bevacizumab for advanced non-small cell lung cancer
Region
Japan

Condition
Condition non-squamous non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of efficacy and safety of Pemetrexed and Carboplatin plus Bevacizumab followed by Pemetrexed and Bevacizumab maintenance therapy for advanced non-squamous non-small-cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes response rate, feasibility
Key secondary outcomes safety,progression free survival,time to response,overall survival

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 Patients recieve Pemetrexed(500mg/m2 ,div), Carboplatin(AUC6 ,div), and Bevacizumab(15mg/kg ,div) on day1,every 3 weeks, up to 6 cycles. Patients who still control disease without unacceptable toxity, then continuously treated with Pemetrexed(500mg/m2 ,div)and Bevacizumab(15mg/kg ,div) on day1, every 3 weeks, 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)historogically or cytologically comfirmed non-squamous non-small-cell lung cancer
2) stageIIIB/IV(UICC-7) or postoperative recurrence non-squamous non-small-cell lung cancer
3)chemo-naive patients
4)age : 20-74 years old
5)ECOG performance status of 0 or 1
6)measurable by RECIST(ver 1.1) criteria
7)if the patient underwent therapy, there should be the following interval between the therapy and the registration
1. radiotherapy other than thoracic radiation >= 2 weeks
2.surgery >= 4 weeks
3.thoracic drainarge >= 2 weeks
4.open biopsy, CV-port reservation, and treatment of injury >= 2 weeks
5.aspiration biopsy >= 1week
8) adequate major organ(hematologic,hepatic,respiratory,and renal) function
1.neutrophil >= 1500mm3
2.platelet >= 100000mm3
3.hemoglobin >= 9.0g/dL
4.AST/ALT <= 2.5 times upper limit of normal
5.total bilirubin <= 1.5 times upper limit of normal
6.predicted creatinin clearance or 24-h creatinine clearance >= 45mL/min
7.SpO >= 93%
8.urine protein <= 1+ or <= 2g/day
9)life expectancy more than 3 months
10)written informed consent
Key exclusion criteria 1)Uncontrolled infection or serious medical complications
2)massive pleural effusion or ascites(accept controrable pleural effusion with OK-432)
3)brain metastasis
4)history of severe cardiac disease
5)uncontrollable diabetes
6)recieving anticoagulant drug(except Aspirin under 324mg/day)
7)history of gross hemoptysis(>2.6ml)
8)history of severe hemosputum(over 1week, or reciving hemostatic drug)
9)uncontrollable hypertension
10)history of GI perfortion(within the last 1 year)
11)history of myocardial infarction or cerebral infarction
12)interstitial pneumonia or pulmonary fibrosis detectable on CT scan
13)history of drug-indused pneumonitis
14)the operation has been scheduled for the examination period
15)treatment history of Pemetrexed, Carboplatin, and Bevacizumab
16)severe drug allegy
17)not reciving folic acid and vitamin B12
18)active concomitant malignancy
19)history of severe mental disorder
20)now pregnant or lactation
21)judged to be not suitable by the attending physician
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Gemma
Organization Nippon Medical School
Division name Department of Internal Medicine, Division of Pulmonary Medicine, Infectious Diseases, and Oncology
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kitamura
Organization Nippon Medical School
Division name Department of Internal Medicine, Division of Pulmonary Medicine, Infectious Diseases, and Oncology
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL 03-3822-2131(6651)
Homepage URL
Email kazu-k@nms.ac.jp

Sponsor
Institute Nippon Medical School Hospital
Institute
Department

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 日本医科大学付属病院(東京都),日本医科大学多摩永山病院(東京都),日本医科大学千葉北総病院(千葉県),埼玉医科大学総合医療センター(埼玉県),財団法人結核予防会複十字病院(東京都),慈山会医学研究所付属坪井病院(福島県)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially 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 16 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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 05 Month 31 Day
Last modified on
2013 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004461

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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