non-squamous non-small cell lung cancer.
Conditions
Interventions
Sponsors
First Department of Internal Medicine,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Overall Survival Safety Profile | — |
Countries
Japan
Contacts
Public ContactYosuke Tamura
Osaka Medical College First Department of Internal Medicine
Outcome results
None listed