Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for 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

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to compare the effectiveness of the three-drug combination paclitaxel, carboplatin, and gemcitabine to the two-drug combination gemcitabine and vinorelbine in patients with advanced Non-Small Cell Lung Cancer

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Detailed Description

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Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

* Paclitaxel + Carboplatin + Gemcitabine
* Gemcitabine + Vinorelbine

For ever 2 patients treated, 1 will receive treatment A (Paclitaxel + Carboplatin + Gemcitabine) and 1 will receive treatment B (Gemcitabine + Vinorelbine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paclitaxel

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Vinorelbine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

To be included in this study, you must meet the following criteria:

* Non-small cell bronchogenic carcinoma
* Newly diagnosed unresectable stage IIIB or stage IV disease
* Patients with stage IIIB disease should be ineligible for combined therapy
* Patients must have measurable lesion definable by X-ray or CT scan.
* No prior antineoplastic chemotherapy for lung cancer prior to study entry
* Age \> 18 years
* Able to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* Written informed consent must be obtained prior to study entry
* Patients must be available for treatment and followup.

Exclusion Criteria

You cannot participate in this study if any of the following apply to you:

* Female patient pregnant or lactating
* History of heart disease
* Serious active infection at the time of treatment
* Other serious underlying medical condition
* Brain metastasis
* Patients without measurable disease
* Uncontrolled diabetes mellitus defined as random blood sugar \> 250mg/dL
* Dementia or significantly altered mental status
* Significant peripheral neuropathy by history or physical examination.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No