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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193362

Enrollment

200

Registered

2005-09-19

Start date

2004-06-30

Completion date

2007-09-30

Last updated

2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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

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.

Interventions

DRUGPaclitaxel

DRUGCarboplatin

DRUGGemcitabine

DRUGVinorelbine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Overall survival.	—

Secondary

Measure	Time frame
Overall toxicity	—
Overall response rate	—
Time-to-progression	—
Assess the quality of life	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026