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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Sarah Cannon Research Institute Eli Lilly and Company GlaxoSmithKline
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193362

Purpose

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	Intervention	Phase
Lung Cancer	Drug: Paclitaxel Drug: Carboplatin Drug: Gemcitabine Drug: Vinorelbine	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall survival.

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	June 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193362

Sponsors and Collaborators

Sarah Cannon Research Institute

Eli Lilly and Company

GlaxoSmithKline

Investigators

Principal Investigator:

Anthony Greco, MD

Sarah Cannon Research Institute

More Information

Study ID Numbers:	SCRI LUN 54, B9E-MC-X338, VNR-R47
Study First Received:	September 12, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00193362
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Vinorelbine
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Carboplatin
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors

Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 15, 2009