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Phase2 Trial of Carboplatin-Paclitaxel bi-weekly and Bevacizumab combination therapy for Elderly Patients With Nonsquamous Non-Small-Cell Lung Cancer

Phase 2
Conditions
onsquamous Non-Small-Cell Lung Cancer
Registration Number
JPRN-UMIN000006525
Lead Sponsor
Shimane University, School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
23
Inclusion Criteria

Not provided

Exclusion Criteria

1) Squamous cell carcinoma. 2) Patients with double cancer. 3) Plan on Concurrent Radiotherapy. 4) Patients with active severe infections. 5) Patients with brain metastasis. 6) History of hemoptysis. 7) Cavity in tumor. 8) Have a bleeding diathesis. 9) Concurrent use of steroid therapy. 10) Use of flucytosine. 11) History of thrombosis. 12) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites. 13) Patients with active severe comorbidity disease. 14) Patients with serious drug allergic reactions. 15) Patients with active concomitant pregnancy. 16) Inappropriate patients for this study judged by the physicians.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response rate with Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Secondary Outcome Measures
NameTimeMethod
1.Overall Survival 2.Progression-free survival 3.Time to treatment failure 4.Quality of Life(QOL) survey with FACT-L 5.Evaluation of comorbidity and function with CCI and VES-13 survey 6.Safety(adverse outcome) 7.Blood levels of MMP-9 , PIGF and sVEGFR 8.Analysis of polymorphisms in the VEGF gene(VEGF-A/VEGF-R2)
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