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

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.

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Paclitaxel (Genexol®); Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 301-721
      • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paclitaxel (Genexol®) and Cisplatin	Drug: Paclitaxel (Genexol®)
Experimental: Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin	Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response rate	overall responses are complete response and partial response	up to 6 cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	OS was calculated by the time from randomization date to the date of death	up to 3 years
progression-free survival	PFS was calculated by the time from randomization date to objective tumor progression or death.	up to 3 years
toxicity profiles	Incidence of AE, laboratory test results (hematology, blood chemistry, and urine test), physical examination, vital sign, and ECOG performance were used for safety endpoints	up to 6 cycles

Collaborators and Investigators

• Sponsor: Samyang Biopharmaceuticals Corporation
• Investigators: Principal Investigator: Sun Young Kim, Ph.D., Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: GPM-0801