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A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion

A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion - A phase II study of Paclitaxel-vinorelbin for NSCLC patients with malignant pleural effusion

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002379
Enrollment
40
Registered
2009-08-26
Start date
2009-08-01
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

Lung Cancer

Interventions

PTX 70mg/m2 VNR 20mg/m2 every 3 weeks 2-6 courses

Sponsors

Niigata Lung Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1 histologically or cytologically confirmed stage IIIB or IV NSCLC. 2 No prior chemotherapy 3 measurable disease 4 age 20=< 5 performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale 6 adequate bone marrow (leukocyte count > 4,000/mm3, <12,000/mm3, neutrophil count > 2,000/mm3, hemoglobin concentration > 9.5g/dL, platelet count > 100,000 /mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and pulmonary (PaO2 > 60 torr) functions.

Exclusion criteria

Exclusion criteria: 1 active concomitant malignancies or infections 2 past history of severe allergic reactions to drugs 3 other serious complications, such as interstitial pneumonia identified by chest X-ray, uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled diabetes mellitus, liver cirrhosis or hypertension

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Overall survival,safety, toxicity, QOL

Countries

Japan

Contacts

Public ContactHirohisa Yoshizawa

Niigata University Medical and Dental Hospital Bioscience Medical Research Center

hy0522@med.niigata-u.ac.jp025-227-2517

Outcome results

None listed

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