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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003263
Receipt No. R000003953
Scientific Title A Phase 2 Study of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Date of disclosure of the study information 2010/02/27
Last modified on 2018/01/05

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Basic information
Public title A Phase 2 Study of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Acronym A Phase 2 Study of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Scientific Title A Phase 2 Study of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Scientific Title:Acronym A Phase 2 Study of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Region
Japan

Condition
Condition Non-squamous Non-small-cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Bevacizumab in Combination with Carboplatin and Paclitaxel in Patients with Non-Squamous Non-Small-Cell Lung Cancer harboring Mutations of EGFR after failing First-line EGFR-TKIs
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Overall survival
Progression free survival
Disease control rate
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 Carboplatin AUC 5 or 6 day 1+Paclitaxel 200mg/m2 day 1+Bevacizumab 15 mg/kg day 1 q3w 3-6 cycles
followed by Bevacizumab 15 mg/kg day 1 q3w 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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically or cytologically proven non-squamous non-small cell lung cancer
2)Non-squamous non-small cell lung cancer harboring mutations of EGFR patients with stage IIIB,stage IV (UICC-7) or recurrent disease after surgery,who have previously treated EGFR-TKIs
3)With measurable lesion(RECIST version 1.1)
4)More than 1 week after the last EGFR-TKIs
5)If the patient underwent therapy, there should be the following interval between the therapy and the registration
i)Radiotherapy other than thoracic radiation ->1 week
ii)Radiotherapy including pulmonary field ->3 months
iii)Surgery(except CV-port reservation) ->4 weeks
iv)Thoracic drainarge ->2 weeks
v)Open biopsy, treatment of injury ->2 weeks
vi)Aspiration biopsy, CV-port reservation ->1 week
6)Age: 20-74 years old
7)ECOG PS 0-1
8)Adequate organ function
9)Life expectancy more than 3 months
10)Written informed consent
Key exclusion criteria 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan
2)History of drug induced interstitial pneumonia
3)History of severe drug allergy
4)History of active infection or other serious disease condition (GI bleeding,etc.)
5)History of poorly controlled pleural effusion,pericardial effusion and ascites
6)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.)
7)Uncontrollable hypertension
8)Uncontrollable diabetes mellitus
9)Current or previous history of hemoptysis or hemosputum
10)Current or previous (within the last 1 year) history of cerebrovascular disease
11)Current or previous (within the last 1 year) history of GI perforation
12)Symptomatic brain metastasis
13)Traumatic fracture of unrecovery
14)The operation has been scheduled for the examination period
15)Tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor.
16)Evidence of bleeding diathesis or coagulopathy
17)Thrombosis that need to treat
18)History of active double cancer
19)History of active psychological disease
20)History of pregnancy or lactation
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyako Satouchi
Organization Hyogo Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
TEL 078-929-1151
Email satouchi@hp.pref.hyogo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Hattori
Organization Hyogo Cancer Center
Division name Department of Thoracic Oncology
Zip code
Address 13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
TEL 078-929-1151
Homepage URL
Email hattori@hp.pref.hyogo.jp

Sponsor
Institute Hanshin Cancer Study Group
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 大阪府立成人病センター(大阪府)
神戸大学医学部附属病院(兵庫県)
先端医療センター(兵庫県)
刀根山病院(大阪府)
兵庫県立がんセンター(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 27 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 01 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 03 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 02 Month 27 Day
Last modified on
2018 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003953

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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