UMIN ID: UMIN000006641
Registered date:07/11/2011
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.
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | non-squamous non-small cell lung cancer |
| Date of first enrollment | 2011/11/01 |
| Target sample size | 41 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Docetaxel+Bevacizumab |
Outcome(s)
| Primary Outcome | Response Rate |
|---|---|
| Secondary Outcome | Safety, Progression Free Survival |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 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. |
Related Information
| Primary Sponsor | Kinki University Faculty of Medicine, Nara Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | No Funding Source |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yusaku Akashi |
| Address | 1248-1,Otoda-cho,ikoma-shi,Nara,Japan Japan |
| Telephone | 0743770880 |
| Affiliation | Kinki University Faculty of Medicine, Nara Hospital Department of Medical Oncology |
| scientific contact | |
| Name | Takao Tamura |
| Address | 1248-1,Otoda-cho,ikoma-shi,Nara,Japan Japan |
| Telephone | 0743770880 |
| Affiliation | Kinki University School of Medicine, Nara Hospital Department of Medical Oncology |