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

Study Overview
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Brief Summary
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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.

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel (Genexol®)
* Drug: Paclitaxel loaded polymeric micelle (Genexol-PM®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC