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

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Paclitaxel (Genexol®); Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)

• Registration Number: NCT01023347
• Lead Sponsor: Samyang Biopharmaceuticals Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-11-30
• Primary Completion: 2009-12
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Study Completion: 2012-06
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel (Genexol®) and Cisplatin	Paclitaxel (Genexol®)	-
Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin	Paclitaxel loaded polymeric micelle (Genexol-PM®)	-

Primary Outcome Measures

Name	Time	Method
response rate	up to 6 cycles	overall responses are complete response and partial response

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chungnam National University Hospital; 🇰🇷 Daejeon, Jung-gu, Korea, Republic of