Phase I/II study of Docetaxel with Bevacizumab for refractory and geriatric non-squamous non-small cell lung cancer
- Conditions
- on-Squamous Non-Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000006152
- Lead Sponsor
- Chiba Tokushukai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I : Recommended dose of docetaxel in combination with bevacizumab Phase II : Progression Free Survival
- Secondary Outcome Measures
Name Time Method Phase I Safety Phase II Response Rate Disease Control Rate Overall Survival Safety