A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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)