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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-06-30

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.

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Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel (Genexol®) and Cisplatin

Group Type ACTIVE_COMPARATOR

Paclitaxel (Genexol®)

Intervention Type DRUG

Paclitaxel loaded polymeric micelle (Genexol-PM®) & Cisplatin

Group Type EXPERIMENTAL

Paclitaxel loaded polymeric micelle (Genexol-PM®)

Intervention Type DRUG

Interventions

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Paclitaxel (Genexol®)

Intervention Type DRUG

Paclitaxel loaded polymeric micelle (Genexol-PM®)

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No