UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003263 |
|---|---|
| Receipt number | 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 22:45:30 |
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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
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
hattori@hp.pref.hyogo.jp
Sponsor or person
Institute
Hanshin Cancer Study Group
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003953
| Research Plan | |
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| 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 |
