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

Sponsor

SCRI Development Innovations, LLC (Other)

Overall Status

Completed

CT.gov ID

NCT00193362

Collaborator

Eli Lilly and Company (Industry), GlaxoSmithKline (Industry)

200

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: Paclitaxel Drug: Carboplatin Drug: Gemcitabine Drug: Vinorelbine	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Overall survival. []

Secondary Outcome Measures

Overall toxicity []
Overall response rate []
Time-to-progression []
Assess the quality of life []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.