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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samyang Biopharmaceuticals Corporation
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

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.