Unique ID issued by UMIN | UMIN000005608 |
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Receipt number | R000006627 |
Scientific Title | Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Who Have Failed Previous Treatments-Phase II study- |
Date of disclosure of the study information | 2011/05/23 |
Last modified on | 2015/07/23 13:01:45 |
Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Who Have Failed Previous Treatments-Phase II study-
Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Who Have Failed Previous Treatments-Phase II study-
Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Who Have Failed Previous Treatments-Phase II study-
Weekly Paclitaxel in Combination with Bevacizumab in Patients with Non-Squamous Non-Small Cell Lung Cancer Who Have Failed Previous Treatments-Phase II study-
Japan |
Patients with non-squamous non-small cell lung cancer who have failed previous treatments
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate safety and efficacy of weekly Paclitaxel in combination with Bevacizumab in patients with non-squamous non-small cell lung cancer who have failed previous treatments
Safety,Efficacy
Phase II
Progression free survival
Safety, Disease control rate, Overall response rate, Time to treatment failure, Overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Weekly Paclitaxel in combination with Bevacizumab in patients with non-squamous non-small cell lung cancer
who have failed previous treatments
20 | years-old | <= |
Not applicable |
Male and Female
(1)Histological or cytological diagnosis of non-squamous NSCLC
(2)Provided written consent in person for participation in this study
(3)Age 20 years or older
(4)ECOG Performance Status (PS) 0 to 2
(5)Have measurable lesions according to the Response Evaluation Criteria in Solid Tumors ver1.1
(6)Have adequate function of major organs (bone marrow, liver, kidneys) defined as follows:
Neutrophils>=1,500 /mm3
Platelets>=100,000 /mm3
Hemoglobin>8.0 g/dl
AST and ALT<=100IU/l
Serum creatinine<=1.5 mg/dl
(7)one prior chemotherapy excluded adjuvant chemotherapy and EGFR-TKI
(8)no administration of Paclitaxel previously
(1)Received transfusion or G-CSF within 14 days prior to enrollment
(2)Urine protein>=2+
(3)History of drug allergy
(4)Active multiple cancers
(5)Severe infection
(6)High fever
(7)Abnormal cardiac function
(8)Severe pulmonary disease; Interstitial pneumonia, severe COPD, pulmonary thromboembolism
(9)Need for drainage of pleural effusion, acsites or pericardial effusion
(10)History of hematoemesis, ileus and gastroduodenal ulcer
(11)symptomatic CNS metastases
(12)CNS or Psychological disorders
(13)Medically uncontrolled hypertension or diabetes mellitus
(14)Nonhealing wound and surgery within 4 weeks before treatment
(15)History of hemoptysis; one-half teaspoon of bright red blood per event
(16)Therapeutic anticoagulation(full-dose therapeutic anticoagulation current and recent use of aspirin (>=325 mg/day)
(17)severe bone marrow suppression
(18)Pregnancy or lactation
31
1st name | |
Middle name | |
Last name | Eiji Shimizu |
Faculty of Medicine, Tottori University
Division of Medical Oncology
36-1 Nishi-machi, Yonago-shi, Tottori-ken 683-0805
0859-38-6537
eiji@med.tottori-u.ac.jp
1st name | |
Middle name | |
Last name | Masahiro Kodani |
Faculty of Medicine, Tottori University
Division of Medical Oncology
36-1 Nishi-machi, Yonago-shi, Tottori-ken
0859-38-6537
kodani@med.tottori-u.ac.jp
Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine Faculty of Medicine, Tottori University
Division of Medical Oncology and Molecular Respirology Department of Multidisciplinary Internal Medicine Faculty of Medicine, Tottori University
Self funding
NO
鳥取大学医学部附属病院、鳥取県立中央病院、松江赤十字病院、米子医療センター、松江医療センター、松江市立病院
2011 | Year | 05 | Month | 23 | Day |
Unpublished
Completed
2011 | Year | 05 | Month | 16 | Day |
2011 | Year | 09 | Month | 01 | Day |
2015 | Year | 02 | Month | 28 | Day |
2015 | Year | 02 | Month | 28 | Day |
2015 | Year | 02 | Month | 28 | Day |
2015 | Year | 02 | Month | 28 | Day |
2011 | Year | 05 | Month | 16 | Day |
2015 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006627
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