Unique ID issued by UMIN | UMIN000006874 |
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Receipt number | R000008123 |
Scientific Title | A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer |
Date of disclosure of the study information | 2011/12/12 |
Last modified on | 2012/11/21 18:27:50 |
A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
Japan |
non-small cell lung cancer
Chest surgery |
Malignancy
NO
To evaluate efficacy and safety of Cisplatin plus Pemetrexed and Bavacizumab in previously treated patients with StageIIIB/IV or recurrent disease non- squamous non-small cell lung cancer
Safety,Efficacy
Phase II
Two years overall survival rate
Progression-free survival, Overall survival, Time to Treatment Failure, Response rate, Disease control rate, Adverse events, Response rate of each EGFR status, Biomarkers
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients were given Cisplatin (75mg/m2, div), Pemetrexed (500mg/m2, div) and Bevacizumab (15mg/kg, div) on day 1, every 3 weeks, up to 6 courses more than 4 courses. Patients without unacceptable toxity, then continuously are treated with Pemetrexed (500mg/m2) and Bevacizumab (15mg/kg, div) on day 1, every 3 weeks, until disease progression.
20 | years-old | <= |
Not applicable |
Male and Female
1)histologically or cytologically confirmed non-squamous non-small-cell lung cancer
2)stage IIIB/IV or postoperative recurrence patients
3)chemotheraoy naive patients
4)Performance Status(ECOG) 0-1
5)Patient who has at least one or more measurable lesion by RECIST
6)Patients aged 20 years or older
7)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria
*Leukocyte counts >= 3,000/mm3
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
*Total bilirubin <=1.5mg/dL.
*Serum creatinin, x 1.5 of ULN or less.
*Electrocardiogram Nomal
*SpO2 >=90% or SaPO2 >=65mmHg
*Protein urea >= 1+
8)Patients who are considered to survive for more than 3 months.
9)interval:
(1)Radiation
*More than 2 weeks after the last irradiation to other organs.
(2)Operation (including pleurodesis)
*More than 4 weeks after the operation without Lobectomy (including exploratory surgery)
*More than 2 weeks after the last operation (including pleurodesis)
10)Patients providing written informed consent
1)Patients with untreated Brain metastases
2)Patients with current or previous history of hemoptysis (2.5mL or more)
3)Patients with uncontrolled hyper tension
4)Patients with uncontrolled infection
5)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis
6)Patients with uncontrollable complications
7)Patients with massive pleural or pericardial effusion,or ascites
8)Patients with active concomitant malignancy
9)Patients with previous histories of drug allergy
10)Patients with uncontrollable gastrointestinal ulceration
11)Patients with current or previous (within one year) history of gastrointestinal perforation
12)Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day)
13)Pregnancy or lactation
14)Inappropriate patients for this study judged by the physicians
37
1st name | |
Middle name | |
Last name | Hiroyuki Suzuki |
Fukushima medical University
Department of Regenerative Surgery
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
1st name | |
Middle name | |
Last name | Hiroyuki Suzuki |
Fukushima medical University
Department of Regenerative Surgery
1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
024-547-1111
Fukushima medical University
None
Self funding
Shirakawa Kosei General Hosptal
Takeda General Hospital
Fukushima Red Cross Hospital
Fukushima accident Hospital
Southern TOHOKU General Hospital
NO
福島県立医科大学附属病院 (福島県)
白河厚生総合病院 (福島県)
竹田綜合病院 (福島県)
福島赤十字病院 (福島県)
福島労災病院 (福島県)
総合南東北病院 (福島県)
2011 | Year | 12 | Month | 12 | Day |
Unpublished
Open public recruiting
2011 | Year | 12 | Month | 09 | Day |
2012 | Year | 01 | Month | 01 | Day |
2011 | Year | 12 | Month | 12 | Day |
2012 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008123
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