Non-Squamous Non-Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Chiba Tokushukai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed Stage IIIB/IV non-squamous non-small cell lung cancer 2) 70<= years 3) Previously treated one chemotherapy regimen (without Docetaxel) 4) With one or more measurable disease based on RECIST (ver.1.1) 5) No chemotherapy within 21days prior to the study. 6) Performance Status (ECOG) : 0-2 7) Adequate function of vital organs, including normal hematopoietic liver and renal function as following: WBC >= 3,000/mm3 Neutrophils >= 1,500/mm3 Hemoglobin >= 9.0 g/dL Platelets >= 75,000/mm3 AST and ALT < 100IU/I Total bilirubin <= 1.5mg/mL Serum creatinine <= 1.5mg/dL PT-INR <1.5 Urinary protein <= 1+ 8) A life expectancy of more than 3 months 9) Written informed consent before initiation of study-related procedures No operation or radiotherapy within 56days prior to the study. No pleurodesis, pleural drainage etc. within 28days prior to the study
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis 2) History of active double cancer within 5 years prior to the study 3) Severe infection 4) History of hemoptysis with 2.5mL or more 5) Continued bloody phlegm 6) Receiving anticoagulant drug(including Aspirin over 325mg/day) 7) Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year. 8) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc) 9) Arterial thromboembolism and Venous thromboembolism within the past one year. 10)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 11) Neuropathy or edema 12) History of hypersensitivity reaction to drugs formulated with polysorbate. 13) Planning of surgery or thoracic radiotherapy during the trial. 14) Uncured major wound 15) With a history of drug sensitivity for Taxotere injection or Avastin injection. 16) No abnormal findings requiring treatment in the electrocardiogram 17) 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 |
|---|---|
| Phase I : Recommended dose of docetaxel in combination with bevacizumab Phase II : Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I Safety Phase II Response Rate Disease Control Rate Overall Survival Safety | — |
Countries
Japan
Contacts
Public ContactShinichiro Okada
Chiba Tokushukai Hospital Department of Thoracic Surgery and Medicine
Outcome results
None listed