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

Samyang Biopharmaceuticals Corporation

Status and phase

Completed

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)

Drug: Paclitaxel (Genexol®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01023347

GPM-0801

Details and patient eligibility

About

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.

Enrollment

276 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.