Unique ID issued by UMIN | UMIN000006322 |
---|---|
Receipt number | R000007381 |
Scientific Title | A phase II study of Bevacizumab and Docetaxel for elderly patients advanced Non-Small Cell Lung Cancer |
Date of disclosure of the study information | 2011/09/12 |
Last modified on | 2011/09/10 12:14:22 |
A phase II study of Bevacizumab and Docetaxel for elderly patients advanced Non-Small Cell Lung Cancer
A phase II study of Bevacizumab and Docetaxel for elderly patients with NSCLC
A phase II study of Bevacizumab and Docetaxel for elderly patients advanced Non-Small Cell Lung Cancer
A phase II study of Bevacizumab and Docetaxel for elderly patients with NSCLC
Japan |
Non-squamous non-small cell lung cancer
Pneumology |
Malignancy
NO
To investigate the efficacy and safety of Docetaxel with Bevacizumab in chemotherapy for elderly patients
with advanced non-squamous non-small-cell lung cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
RR: response rate
PFS: progression free survival
OS: overall survival
safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
DTX+BEV
70 | years-old | <= |
Not applicable |
Male and Female
1)Histologically or cytrologically confirmed diagnosis of NSCLC (Non squamous cell carcinima)
2)No prior systemic treatment advanced NSCLC
3)Tumors must have measurable disease
4)ECOG performance status 0 or 1
5)Patients aged 70- years
6)Written informed consent from the patients
7)No problem adequate organ function
1)Subjects with interstitial pneumonia or pulmonary fibrosis.
2)Uncontrolled systematic disease
3)Uncontrolled active infection
4)No other active malignancies
5)Concurrent use of steroid therapy
6)Subjects with brain metastases
7)Uncontrolled pleural effusion and ascites
8)have had or require continuous oral administration of hemostat/have had or require injectable administration of hemostat
9)Pregnant patients
10)Have a bleeding diathesis
11)Tumor invasion to major vessels
12)Cavity in tumor
13)History of uncontrolled gastroduodenal ulcer
14)Uncontrolled hypertension
15)Symptomatic heart failure,unstable angina, uncontrolled arrhythmia,
myocardial infarction within 1 year
16)Symptomatic cerebrovasucular disease
17)Any other reason that,in the opinion of the investugator precludes the subject from participating in the study.
30
1st name | |
Middle name | |
Last name | Takeshi Morimoto |
University hospital, Hirosaki University School of Medicine
Cardiology,respiratory medicine and nephrology
5 Zaifu-cho, Hirosaki, 036-8562 Japan
1st name | |
Middle name | |
Last name | Hisashi Tanaka |
University hospital, Hirosaki University School of Medicine
Cardiology,respiratory medicine and nephrology
5 Zaifu-cho, Hirosaki, 036-8562 Japan
University hospital, Hirosaki University School of Medicine
Cardiology,respiratory medicine and nephrology
none
Self funding
Hirosaki Central Hospital
Natonal Hospital Orgnization Hirosaki Hospital
NO
2011 | Year | 09 | Month | 12 | Day |
Unpublished
Open public recruiting
2011 | Year | 08 | Month | 23 | Day |
2011 | Year | 08 | Month | 01 | Day |
2011 | Year | 09 | Month | 10 | Day |
2011 | Year | 09 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007381