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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006525

Enrollment

Registered

2011-10-12

Start date

2011-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonsquamous Non-Small-Cell Lung Cancer

Interventions

Carboplatin AUC=3, intravenous bi-weekly Paclitaxel 90mg/m2,intravenous bi-weekly Bevacizumab 15mg/kg, intravenous q4w Maintenance

Bevacizumab 15mg/kg, intravenous q3w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically proven Nonsquamous and Nonsmall cell lung cancer. 2) Patient who has at least one or more measurable lesion by RECIST criteria. 3) 1st line or more than 30 days after last chemotherapy (EGFR-I only) . 4) ECOG performance status (PS): 0-1 5) Patients aged of 70 years or over. 6) Sufficient function of main organ and bone marrow filled the following criteria: Leukocyte counts, 3,000/mm3 or over. Neutrophil counts, 1,500/mm3 or over. Platelets, 100,000/mm3 or over. Hemoglobin, 9.0g/dL or over. AST and ALT, 150 IU/L or less. Serum bilirubin, 1.5mg/dl or less. Serum creatinin, 1.5 mg/dL or less. Adequate heart function by ECG. Proteinuria 1+ or less. 7)Provided written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Response rate with Response Evaluation Criteria In Solid Tumors (RECIST) criteria	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactTakmasa Hotta

Shimane University, School of Medicine Division of Clinical Oncology and Respiratory Medicine

takamasa@med.shimane-u.ac.jp0853-20-2581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026