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 |
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
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
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
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
Japan |
Non-squamous Non-small-cell Lung Cancer
Pneumology |
Malignancy
YES
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
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response rate
Overall survival
Progression free survival
Disease control rate
Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
20 | years-old | <= |
74 | years-old | >= |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Miyako Satouchi |
Hyogo Cancer Center
Department of Thoracic Oncology
13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
078-929-1151
satouchi@hp.pref.hyogo.jp
1st name | |
Middle name | |
Last name | Yoshihiro Hattori |
Hyogo Cancer Center
Department of Thoracic Oncology
13-70, Kitaouji-cho, Akashi, Hyogo 673-8558, Japan
078-929-1151
hattori@hp.pref.hyogo.jp
Hanshin Cancer Study Group
None
Self funding
NO
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)
2010 | Year | 02 | Month | 27 | Day |
Published
Completed
2010 | Year | 01 | Month | 28 | Day |
2010 | Year | 03 | Month | 01 | Day |
2010 | Year | 02 | Month | 27 | Day |
2018 | Year | 01 | Month | 05 | Day |
Value
https://center6.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 |