Unique ID issued by UMIN | UMIN000008687 |
---|---|
Receipt number | R000010206 |
Scientific Title | A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer. |
Date of disclosure of the study information | 2012/08/20 |
Last modified on | 2016/02/27 07:43:22 |
A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.
A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.
A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.
A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.
Japan |
non-squamous non-small cell lung cancer.
Pneumology |
Malignancy
NO
A phase II study of Docetaxel with Bevacizumab for previously treated non-squamous non-small cell lung cancer.
Safety,Efficacy
Progression Free Survival
Response Rate
Overall Survival
Safety Profile
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Docetaxel with Bevacizumab
20 | years-old | <= |
Not applicable |
Male and Female
1. Histologically or cytologically confirmed non-squamous non-small cell lung cancer.
2. Clinical stage IIIB/IV NSCLC without any indications for radiotherapy or surgery.
3. Relapsed or progressed to one prior treatment with a platinum-based chemotherapy on the image.
4. Relapsed or progressed to only one prior chemotherapy (A patient with history of treatment with EGFR-TKI or UFT as adjuvant regimen is eligible.)
5. No chemotherapy (or EGFR-TKI)within 4wks prior to the study.
6.No Surgery within 4wks prior to the study.
7. No radiotherapy within 2wks prior to the study.
8. With one or more measurable disease based on RECIST.
9. 20<= years.
10. Performance status (ECOG) : 0-2.
11. Adequate function of vital organs as following:
WBC >= 3,000/mm3
Neutrophils >= 1,500/mm3
Platelets >= 100,000/mm3
Hemoglobin >= 9.0 g/dL
AST and ALT <= 2.5ULN
Total bilirubin <= 1.5ULN
Serum creatinine <= 1.5mg/dL
PaO2<=60mmHg or SpO2<=93%
12. A life expectancy of more than 3 months.
13. Written informed consent before initiation of study-related procedures.
1. Prior treatment with Docetaxel.
2. History or complication of hemoptysis with 2.5mL per time or more.
3.Patients with lesions at risk of causing hemoptysis in hilar by chest CT.
4. Invasion to major vessel of tumor.
5. Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
6.Have uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management).
7. Planning of concurrent thoracic radiotherapy (including if radiation field does not cover the chest).
8. Have active CNS metastases.
9. Have another active malignancy.
10. Major surgery within 4wks prior to the study.
11. Urinary protein <= 2+
12. Patients with therapeutic anticoagulopathy.
13. Have a history of serious systemic disease.
14. In pregnancy, during breast feeding, or possibility of pregnancy.
15. With a history of serious drug sensitivity.
16. Mental disease or psychotic manifestation.
17. Severe infection such as having a HCV Ab positive or HbsAg positive.
18. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
25
1st name | |
Middle name | |
Last name | Isao Goto |
Osaka Medical College
First Department of Internal Medicine,
2-7,Daigaku-machi Takatsuki-city Osaka 569-8686 JAPAN
072-683-1221
1st name | |
Middle name | |
Last name | Yosuke Tamura |
Osaka Medical College
First Department of Internal Medicine
2-7,Daigaku-machi Takatsuki-city Osaka 569-8686 JAPAN
072-683-1221
First Department of Internal Medicine,
None
Self funding
NO
2012 | Year | 08 | Month | 20 | Day |
Unpublished
Completed
2012 | Year | 04 | Month | 24 | Day |
2012 | Year | 08 | Month | 20 | Day |
2012 | Year | 08 | Month | 14 | Day |
2016 | Year | 02 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010206