Previously treated non-small cell lung cancer
Conditions
Interventions
bevacizumab and S-1
Sponsors
Thoracic Medical Oncology Cancer Institute Hospital of Japanese Foundation for Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed Stage IIIB/IV non-squamous non-small cell lung cancer 2) Previously treated one or more chemotherapy regimens 3) With one or more measurable disease based on RECIST (ver.1.1) 4) Performance Status (ECOG) : 0-1 5) 20<= years 6) Patients providing written informed consent 7) Adequate function of vital organs, including normal hematopoietic liver and renal function as following: WBC >= 3,000/mm3 or Neutrophils >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelets >= 100,000/mm3 AST and ALT, x 2.5 of upper limit of normal (ULN) or less. Total bilirubin <= 1.5mg/mL Serum creatinine <= 1.5mg/dL Creatinin crealance>=30mL/min PT-INR <1.5 Urinary protein <2+ PaO2>=60torr or SpO2>=95% 8)interval: (1) chemotherapy, more than 3 weeks after the last chemotherapy. (2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs. (3) Operation, more than 4 weeks after the last operation (including pleurodesis) 9) A life expectancy of more than 3 months
Exclusion criteria
Exclusion criteria: 1)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 2)Patients with uncontrollable complications(e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea). 3)Patients with active severe infections. 4)History of active double cancer within 5 years prior to the study. 6)Patients with symptomatic brain metastasis 7) 8)History of hemoptysis with 2.5mL or more and Continued bloody phlegm. 9)Pregnancy or lactation 10)evidence of bleeding diathesis or coagulopathy 11)tumor invasive to the chest large blood vessel. Cavity in brain or lung tumor 12)current or previous (within the last 1 year) history of GI perforation 13)current history of uncontrorable hypertension 14)Impossible cases with oral administration. 15)severe drug allergy for 5-FU or UFT or S-1 content medicine 16) 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 |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, objective response rate , progression free survival | — |
Countries
Japan
Contacts
Public ContactAtsushi Horiike
Cancer Institute Hospital of Japanese Foudation for Ccancer Research Toracic Medical Oncology
Outcome results
None listed