Unique ID issued by UMIN | UMIN000006641 |
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Receipt number | R000007855 |
Scientific Title | A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy. |
Date of disclosure of the study information | 2011/11/07 |
Last modified on | 2011/11/01 12:59:41 |
A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
A Phase 2 study of Docetaxel and Bevacizumab as the second line treatment for patients with non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy.
Japan |
non-squamous non-small cell lung cancer
Pneumology | Hematology and clinical oncology |
Malignancy
NO
To evaluate the safety and efficacy of Docetaxel and Bevacizumab in a phase II clinical study for patients previously treated advanced non-squamous non small cell lung cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Response Rate
Safety, Progression Free Survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Docetaxel+Bevacizumab
20 | years-old | <= |
Not applicable |
Male and Female
1.Histologically or cytologically confirmed non-squamous non-small cell lung cancer
2.Stage 3/4 unresectable or unsuitable for radical irradiation
3.Relapsed or progressed to one prior chemotherapy
4. The prior chemotherapy is only one regimen.
5. With measurable disease (based on RECIST ver1.1)
6. Age >= 20
7. Performance status (ECOG) : 0 or 1, 2
8. Adequate function of vital organs as following;(within two weeks before registration)
Neutrophils >= 1,500/mm3
Platelets >= 100,000/mm3
Hemoglobin >= 8.5 g/dL
AST/ALT <= 2.5ULN
Total bilirubin <= 1.5mg/dL
Serum creatinine <= 1.5mg/dL
PaO2 >= 60mmHg or SpO2 >= 92%
9. A life expectancy of more than 3 months
10. Written informed consent before initiation of study-related procedures
1. No prior treatment with Docetaxel and Bevacizumab
2.History of hemoptysis with 2.5mL per time or more.
3.Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
4.massive pleural or pericardial effusion.
5. CNS metastasis
6. Patients with a concomitant or prior invasive malignancy who have had any evidence of the disease within the last 5 years
7. Patients with severe complications
Unstable angina. cardiovascular disease, severe heart disease, heart failure within 3month.
Uncontrollable diabetes mellitus and hypertension
Active infection
8. In pregnancy, during breast feeding, or possibility of pregnancy.
9.The past history of severe allergic reactions
10. psychiatric patients
11. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
41
1st name | |
Middle name | |
Last name | Takao Tamura |
Kinki University School of Medicine, Nara Hospital
Department of Medical Oncology
1248-1,Otoda-cho,ikoma-shi,Nara,Japan
0743770880
1st name | |
Middle name | |
Last name | Yusaku Akashi |
Kinki University Faculty of Medicine, Nara Hospital
Department of Medical Oncology
1248-1,Otoda-cho,ikoma-shi,Nara,Japan
0743770880
Kinki University Faculty of Medicine, Nara Hospital
No Funding Source
Self funding
NO
近畿大学医学部奈良病院(奈良県)
2011 | Year | 11 | Month | 07 | Day |
Unpublished
Open public recruiting
2011 | Year | 10 | Month | 03 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
2011 | Year | 11 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007855
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