Non-squamous non-small cell lung cancer
Conditions
Interventions
Docetaxel and bevacizumab will be administered triweekly until disease progression.
Sponsors
Department of Pulmonary Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Written informed consent (2) It is judged by investigators to be treatable in this protocol (3) Radical radiation therapy cannot adapt (case of clinical stage of a disease IIIB, IV). After failure to first line therapy, platinum doublet * EGFR-TKI is not regard as a series of first line therapy * Previously treated with one cytotoxic chemotherapy regimen * Palliative radiation therapy (gamma-knife, hole brain irradiation, or irradiation to a bone metastatic ) to any place other than the original lesion genesis can register if there is it more than 2 weeks after the radiation therapy(registration is possible from day 15 as day0 on last treatment day) (4) age>=20years (5) With measurable lesion(RECIST version 1.1) (6) ECOG PS 0-2 (7) Adequate organ function WBC >=3,000/mm3,&not; Neu >=1,500/mm3, Platelet >=100,000/mm3 ,Hb >=8.5 g/dl ,ALT,AST <=2.5 x the Upper Limits of Normal (ULN) (liver metastasis<=5.0 x ULN), T-bilirubin<=1.5 mg/dl , CCr-50 ml/min (Cockcroft & Gault), ECG (within normal limit) ,SpO2>=94% , Urine protein<= 1+ or 2 g in urine collection for 24h (8) Life expectancy more than 3 months
Exclusion criteria
Exclusion criteria: (1) Squamous metastasis (2) No prior platinum-based chemotherapy as first- line therapy (3) No prior docetaxel or bevacizumab as first- line therapy (4) Having serious complications. ex): a serious heart disease , cerebrovascular disorder, diabetes that it is hard to control or hypertention , a severe infection, pulmonary fibrosis, interstitial pneumonia, respiratory failure, bleeding, a large quantity of hydrothorax or abdominal dropsy retention, peptic ulcer of the activity, serious nerve disease (5) Symptomatic brain metastasis (6) With pulmonary cavitary lesions (7) Have an anamnesis and the complications , expectoration of fresh blood more than 2.5 ml due to non-small-cell lung cancer (8) Having an anamnesis of the following bloody phlegm or complications * there is the dosage career when bloody phlegm occurring continuously (more than one week) or the anamnesis or the internal use styptic is continuous(the cases that an internal use styptic was necessary for again after having been relieved using an internal use styptic or the bloody phlegm which needs with a history of bloody phlegm, the dosage of the injection styptic to need the dosage or the dosage) (9) Uncontrollable hypertension (10) Current or previous (within the last 1 year) history of GI perforation (11) The operation has been scheduled for the examination period (12) Have multiple primary cancer (13) History of serious drug hypersensitivity (14) Pregnancy or lactation (15) Active psychological disease (16) Patients who have received a radiation therapy in chest (17) Receives the steroid continuously(p.o. or i.v.) (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 |
|---|---|
| Safety, Response rate, Overall survival | — |
Countries
Japan
Contacts
Public ContactHironobu Kanazawa
Graduate School of Medical and Dental Sciences, Kagoshima University Pulmonary medicine
Outcome results
None listed