A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Samyang Biopharmaceuticals Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Contraindication to any drug contained in the chemotherapy regimen
Pregnant or lactating women were excluded.
Clareo Health | A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer
