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Vinorelbine-carboplatin for patients with stage IIIB, IV non-small cell lung cancer:a phase II study of the Niigata Lung Cancer Treatment Group

Vinorelbine-carboplatin for patients with stage IIIB, IV non-small cell lung cancer:a phase II study of the Niigata Lung Cancer Treatment Group - Vinorelbine-carboplatin for patients with stage IIIB, IV non-small cell lung cancer:a phase II study of the Niigata Lung Cancer Treatment Group

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001134
Enrollment
35
Registered
2008-04-28
Start date
2003-11-01
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

Non-small cell lung cancer

Interventions

VNR 25mg/m2 day1,8 CBDCA AUC=5 day1

Sponsors

Niigata Lung Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients enrolled in this trial had histologically or cytologically confirmed stage IIIB or IV NSCLC. Patients with stage IIIB disease who were not candidates for thoracic radiation and those with stage IV disease were eligible, if they had not received previous chemotherapy, had measurable disease, and had a life expectancy of at least 3 months. Additional entry criteria were age 20=< ,<70 years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and 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: Patients were excluded if they had any active concomitant malignancies,infections, symptomatic brain metastases, past history of severe allergic reactions to drugs, interstitial pneumonia identified by chest X-ray, or other serious complications, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.

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