A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer

Inclusion Criteria: * Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv) * At least one measurable lesion(s) by RECIST criteria * No previous palliative chemotherapy * Age 18 or higher. * ECOG PS 0-2 * Life expectancy of at least 3 months. * Adequate hematologic, hepatic, renal function * Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul) * Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5 upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit) * Adequate renal function (≤ serum creatinine 1.5 mg/dl) * Written informed consent Exclusion Criteria: * No prior chemotherapy for NSCLC * Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix. * Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0) * Clinically significant cardiac disease (medically uncontrollable heart disease) * Active infection or other serious medical illness * Contraindication to any drug contained in the chemotherapy regimen * Pregnant or lactating women were excluded.