UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003680 |
|---|---|
| Receipt number | 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 14:06:45 |
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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
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
kazu-k@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004461
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
