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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SCRI Development Innovations, LLC
• Collaborators: Eli Lilly and Company; GlaxoSmithKline
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Paclitaxel; Vinblastine; Vinorelbine

Criteria

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.