Unique ID issued by UMIN | UMIN000013202 |
---|---|
Receipt number | R000015399 |
Scientific Title | A phaseI/II study of Erlotinib/Carboplatin/Pemetrexed/Bevacizumab in chemotherapy-naive patients with EGFR mutation positive advanced non-squamous non-small-cell lung cancer |
Date of disclosure of the study information | 2014/02/19 |
Last modified on | 2014/02/19 20:42:37 |
A phaseI/II study of Erlotinib/Carboplatin/Pemetrexed/Bevacizumab in chemotherapy-naive patients with EGFR mutation positive advanced non-squamous non-small-cell lung cancer
A phaseI/II study of Erlotinib/Carboplatin/Pemetrexed/Bevacizumab in chemotherapy-naive patients with EGFR mutation positive advanced non-squamous non-small-cell lung cancer
A phaseI/II study of Erlotinib/Carboplatin/Pemetrexed/Bevacizumab in chemotherapy-naive patients with EGFR mutation positive advanced non-squamous non-small-cell lung cancer
A phaseI/II study of Erlotinib/Carboplatin/Pemetrexed/Bevacizumab in chemotherapy-naive patients with EGFR mutation positive advanced non-squamous non-small-cell lung cancer
Japan |
Non-Small-Cell Lung Cancer
Pneumology |
Malignancy
NO
To evaluate the feasibility and efficacy of Erlotinib/Carboplatin/Pemetrexed/Bevacizumab in chemotherapy-naive patients with EGFR mutation positive advanced non-squamous non-small-cell lung cancer.
Safety,Efficacy
Exploratory
Phase I,II
progression free survival
Safety, Response Rate, Disease Control Rate, Overall Survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
level0:Erlotinib 50mg(daily)
level1:Erlotinib 100mg(daily)
level2:Erlotinib 150mg(daily)
level0-2:Carboplatin AUC=6,Day1/Pemetrexed 500mg/m2,Day1/Bevacizumab 15mg/kg,Day1
20 | years-old | <= |
Not applicable |
Male and Female
1) Histologically or cytologically proven non-squamous non-small cell lung cancer
2) Non-small cell lung cancer with stage IIIB,stage IV (UICC-7)
3) EGFR mutation positive
4) chemo naïve
5) Age: 20- years old
6) ECOG PS 0-1
7) Adequate organ function
1)Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
2)History of radiation therapy for chest
3)With hemosputum
4)With active bleeding
5)Symptomatic brain metastasis
6)With active infectious disease
7)History of serious disease condition
8)With massive pleural effusion or ascitis
9)History of active double cancer
10)need to operation
11) History of pregnancy or lactation
12)History of active psychological disease
13) History of drug allergy
35
1st name | |
Middle name | |
Last name | Takayasu Kurata |
Kansai Medical University Hirakata Hospital
Thoracic oncology
2-3-1 Shinmachi,Hirakata,Osaka,Japan
072-804-0101
kuratat@hirakata.kmu.ac.jp
1st name | |
Middle name | |
Last name | Takashi Yokoi |
Kansai Medical University Hirakata Hospital
Thoracic oncology
2-3-1 Shinmachi,Hirakata,Osaka,Japan
072-804-0101
yokoit@hirakata.kmu.ac.jp
Kansai Medical University Hirakata Hospital
Kansai Medical University
Self funding
NO
2014 | Year | 02 | Month | 19 | Day |
Unpublished
Open public recruiting
2013 | Year | 10 | Month | 05 | Day |
2014 | Year | 02 | Month | 19 | Day |
2014 | Year | 02 | Month | 19 | Day |
2014 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015399
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |