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A phase II study of maintenance bevacizumab plus docetaxel following induction chemotherapy with cisplatin, pemetrexed plus bevacizumab for advanced non-squamous non-small-cell lung cancer

Phase 2
Conditions
Advanced non-squamous non-small cell lung cancer
Registration Number
JPRN-UMIN000014314
Lead Sponsor
Hamamatsu Univ. School of Medicine
Brief Summary

The median progression-free survival from enrollment was 7.8 month

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
49
Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria are as follows 1: Squamous cell carcinoma 2: Active interstitial pneumonia identified by chest X-ray 3: Current or previous histoty of hemoptysis (2.5ml) due to NSCLC 4: Uncontrolled massive pleural effusion or cardiac effusion 5: Superior vena cava syndrome 6: Uncontrolled brain metastases 7: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 3 months 8: Severe infection 9: Pregnancy or lactation 10: Active concomitant malignancy 11: History of severe allergic reactions to drugs 12: Evidence of bleeding diathesis or hemoptysis 13: Current or previous history of cerebrovascular disease 14: Current or previous history of GI perforation 15: With great vessel invasion 16: Exposure of the tumor to the central airway 17: Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day or Clopidogrel over 75mg/day) 18: Patients with arterial thrombosis or venous thrombosis 19: Severe and unstable medical comorbidities 20: Judgment to attending physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression free survival
Secondary Outcome Measures
NameTimeMethod
Response rate, disease control rate, overall survival, safety, QOL score(EQ-5D)
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