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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003387
Receipt No. R000004112
Scientific Title Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Date of disclosure of the study information 2010/04/01
Last modified on 2017/08/21

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Basic information
Public title Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Acronym Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Scientific Title Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Scientific Title:Acronym Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive stage IIIB/IV non-squamous non-small cell lung cancer(NSCLC).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response Rate
Key secondary outcomes Progression Free Survival
Overall Survival
Time to Response
Safety

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 receive CBDCA(AUC6,i.v.), Pemetrexed(500mg/m2,i.v.) and Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, up to six cycles.Patients who achieved disease control(response or stable disease) without unacceptable toxicity receive Pemetrexed(500mg/m2,i.v.) and Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, untill disease porogression.
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)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC)
2)Stage IIIB/IV(UICC-7) or postoperative recurrence NSCLC
3)cheno-naive patient(except oral 5-FU)
4)Age:20 years to less than 75 years.
5)ECOG performance status of 0 or 1
6)Measurable by RECST(ver 1.1) criteria.
7)Patient who has the following periods.
palliative radiotherapy(ex thorax):2 weeks
operation:4 weeks
chest drainage:2 weeks
Biopsy with incision, port custody, and treatment to injury:2 weeks
Aspiration biopsy cytology:1 week
8)adequate bone marrow, liver, and renal functions
neutro > 1,500/mm-3
Plt > 100,000/mm-3
Hb > 9.0 g/dL-1
neutro > 2,000 mm-3
AST(GOT), ALT(GPT)< 2.5x upper normal limit
T-Bil< 1.5x upper normal limit
creatinine clearance > 45 ml/min
SpO2> 93%
Urinari protein <= 1+ or 2g/24hrs
9)a life expectancy of 3 months or more
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)current or previous treated brain metastasis
4)severe cardiac disease
5)uncontrolled diabetes mellitus
6)receiving anticoagulant drug(except Aspirin under 325mg/day)
7)current or previous history of hemoptysis(>=2.5ML) due to NSCLC
8)history of hemoptysis(over 1 week) or receive oral/i.v. hemostatic drug
9)uncontrolled hyper tension
10)current or previous (within the last 1 year) history of GI perforation
11)interstitial pneumonia or lung
fibrosis evident on CT
12)history of drug induced interstitial pneumonia
13)Patient who has been scheduling operation for examination period
14)treatment history of carboplatin, pemetrexed and bevacizumab
15)severe drug allergy
16)Patient who cannot or doesn't hope administer multivitamin and vitamin B12
17)active concomitant malignancy
18)severe psychological disease
19)pregnant or lactating women or those who declined contraception
20)those judged to be not suitable by the attending physician
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKASHI YOKOI
Organization Kansai Medical University Hirakata Hospital
Division name respiratory medicine
Zip code
Address 2-3-1, Shinmachi, Hirakata-city, OSAKA
TEL 072-804-0101
Email yokoit@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Yokoi
Organization Kansai Medical University Hirakata Hospital
Division name respiratory medicine
Zip code
Address 2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL 072-804-0101
Homepage URL
Email yokoit@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University Hirakata Hospital
Institute
Department

Funding Source
Organization Kansai Medical University Hirakata Hospital
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 関西医科大学附属枚方病院(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results 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 03 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 27 Day
Last modified on
2017 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004112

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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