Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.

INTERVENTION: docetaxel 60mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1 q3w, 6 cycles paclitaxel 200mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1 q3w, 6 cycles CONDITION: Stage IIIB/IV non‐small cell lung cancer PRIMARY OUTCOME: Progression‐free survival (PFS) SECONDARY OUTCOME: Response rate, 1‐yr survival, overall survival, safety INCLUSION CRITERIA: 1)written informed consent 2)histologically or cytologically confirmed stage IIIB (inoperable or ineligible for curative radiation therapy) or IV NSCLC with no prior chemotherapy. Recurrence after surgery is categorized as stage IV. 3)At least 3 weeks passed and recovered from toxicity from prior radiation therapy or surgery if applicable. 4)Measurable disease. 5)ECOG Performance status 0 or 1. 6)Adequate organ function (1) Neutrophil count >= 2,000/mm3 (2) Platelet count >= 100,000/mm3 (3) Hemoglobin >= 9.0g/dL (4) AST/ALT within twice the upper limit of normal (ULN) of institution (5) Total bilirubin within the ULN (6) Serum creatinine within the ULN (enzyme method) (7) Creatinine clearance >= 50 mL/min 7)PaO2 >= 70 torr or SpO2 >= 94% (room air) 8)Estimated life expectancy longer than 3 months