Randomized phase II study of carboplatin / gemcitabine versus vinorelbine / gemcitabine in patients with advanced non-small cell lung cancer

INTERVENTION: Patients in group one will receive an infusion of gemcitabine on days 1 and 8. They will also receive an infusion of carboplatin on day 1. Patients in group two will receive infusions of gemcitabine and vinorelbine on days 1 and 8. Treatment in all groups may be repeated every 3 weeks for up to six courses. CONDITION: Stage IIIb/IV NSCLC PRIMARY OUTCOME: 1‐year survival rate 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. Patients who had received previous radiotherapy were included, if they had assessable disease outside of the radiation field. Patients with post operative recurrence were also allowed. Additional entry criteria were age 20‐74 years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow (leukocyte count > 3,500/mL, neutrophil count > 2,000/mL, hemoglobin concentration > 10.0 g/dL, platelet count > 100,000 /mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < 2.5