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

This is a randomized clinical 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.