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A phase II study of Docetaxel with Bevacizumab in chemotherapy naïve elderly patients with advanced non-squamous non-small-cell lung cancer

Phase 2
Conditions
on-squamous non-small cell lung cancer
Registration Number
JPRN-UMIN000005619
Lead Sponsor
Osaka Lung Cancer Study Group
Brief Summary

not yet

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

1) squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Pleural effusion, pericardial effusion and ascites to need treatment 4) Severe renal function disorder 5) SVC syndrome 6) Brain metastases with neurological symptoms 7) Active double cancer 8) Uncontrollable diabetes mellitus and hypertenson 9) Liver cirrhosis by image findings or laboratory examinations 10) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.) 11) Pregnancy, breast feeding and suspected pregnancy 12) History of grave drug allergic reaction 13) Acute inflammatory disease 14) An agreement is not obtained for support therapy such as transfusion etc 15) Having the bleeding tendency which is clinically apparent 16) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
RR: response rate
Secondary Outcome Measures
NameTimeMethod
PFS: progression free survival OS: overall survival DCR: disease control rate AE: Adverse events
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