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