Unique ID issued by UMIN | UMIN000016507 |
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Receipt number | R000019170 |
Scientific Title | A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer |
Date of disclosure of the study information | 2015/02/10 |
Last modified on | 2016/02/10 18:33:56 |
A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
A phase II study of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To evaluate feasibility and efficacy of erlotinib plus bevacizumab in patients with performance status 2 to 3 and EGFR mutation-positive advanced non-small-cell lung cancer
Safety,Efficacy
Phase II
Progression free survival
Adverse event, Response rate, Improvement rate of performance status, Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Erlotinib plus bevacizumab
20 | years-old | <= |
Not applicable |
Male and Female
1) Pathologically confirmation of non squamous non-small-cell lung cancer
2) EGFR mutation (exon 19 deletion or L858R in exon 21) proven
3) Stage IIIB/IV and chemo-naive non-small-cell lung cancer
4) ECOG PS 2 or 3
5) Evaluable lesions
6) Aged 20 or more
7) Adequate organ functions
8) Written informed consent
1) EGFR mutation with T790M in exon 20
2) Uncontrolled symptomatic brain metastasis
3) Hemoptysis
4) Bleeding tendency
5) Use of antithrombotic agents
6) Evidence of tumor invading major blood vessel
7) Cavitated tumor
8) Thrombosis
9) Interstitial pneumonia or pulmonary fibrosis on imaging
10) Gastrointestinal disorder
11) Uncontrollable pleural effusion , ascites or pericardial effusion
12) Past given the radiation therapy for chest
13) Active double cancer
14) Severe complication
15) History of severe allergy
21
1st name | |
Middle name | |
Last name | Haruyasu Murakami |
Shizuoka cancer center
Division of Thoracic Oncology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
(+81)055-989-5222
ha.murakami@scchr.jp
1st name | |
Middle name | |
Last name | Kazuhisa Nakashima |
Shizuoka cancer center
Division of Thoracic Oncology
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
(+81)055-989-5222
ka.nakashima@scchr.jp
Shizuoka cancer center
None
Self funding
NO
静岡県立静岡がんセンター(静岡県)
広島市立広島市民病院(広島県)
関西医科大学附属枚方病院(大阪府)
2015 | Year | 02 | Month | 10 | Day |
Unpublished
Terminated
2015 | Year | 01 | Month | 15 | Day |
2015 | Year | 02 | Month | 10 | Day |
2015 | Year | 02 | Month | 10 | Day |
2016 | Year | 02 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019170
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