Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine for Non-Small Cell Lung Cancer

Study Overview
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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

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.

Official Title
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Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: Gemcitabine
* Drug: Vinorelbine


Participation Criteria
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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. Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel|nan|
|Drug: Carboplatin|nan|
|Drug: Gemcitabine|nan|
|Drug: Vinorelbine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall toxicity |  |  | 
| Overall response rate |  |  | 
| Time-to-progression |  |  | 
| Assess the quality of life |  |  |