Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatments paclitaxel (genexol®), paclitaxel loaded polymeric micelle (genexol-pm®)
Phase phase 2
Sponsor Samyang Biopharmaceuticals Corporation
Start date May 2008
Trial size 286 participants
Trial identifier NCT01023347, GPM-0801

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
paclitaxel (genexol®)
(Experimental)
paclitaxel loaded polymeric micelle (genexol-pm®)

Primary Outcomes

Measure
response rate
time frame:

Secondary Outcomes

Measure
overall survival
time frame:
progression-free survival
time frame:
toxicity profiles
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Principal investigator Sun Young Kim, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Samyang Biopharmaceuticals Corporation.