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A phase I study of bevacizumab and amrubicin after platinum-based chemotherapy in patients with advanved non-squamous non-small cell lung cancer

Phase 1
Conditions
on-Small Cell Lung Cancer Non-Squamous cell lung cancer
Registration Number
JPRN-UMIN000008182
Lead Sponsor
ational Hospital Organization Kyushu Medical Center Department of Respiratory Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

1)Squamous cell carcinoma 2)Discontinued bevacizumab due to its toxicity during a first line treatment 3)Serious infections/with fever 4)Serious clinical problems 5)Interstitial pneumonia/lung fibrosis on chest X-ray 6)History or complication of hemoptysis with 2.5ml per time or more 7)Continuous bloody phlegm more than 1 week or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent. 8)Tumor cavitation 9)Uncontrollable hypertension 10)History of GI perforation 11)Previous treatment with amrubicin 12)Massive pericardial, pleural effusion, ascites 13)Active concomitant malignancy 14)Symptomatic brain metastasis 15)Previous drug allergy 16)Those judged to be not suitable by the attending physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Maximum tolerated dose (MTD) of amrubicin and bevacizumab
Secondary Outcome Measures
NameTimeMethod
Anti tumor efficacy
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