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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193362
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : July 28, 2010
Eli Lilly and Company
Information provided by:
SCRI Development Innovations, LLC

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 Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
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 : June 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Overall survival.

Secondary Outcome Measures :
  1. Overall toxicity
  2. Overall response rate
  3. Time-to-progression
  4. Assess the quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193362

Sponsors and Collaborators
SCRI Development Innovations, LLC
Eli Lilly and Company
Principal Investigator: Anthony Greco, MD SCRI Development Innovations, LLC

Additional Information:
Publications of Results: Identifier: NCT00193362     History of Changes
Other Study ID Numbers: SCRI LUN 54
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 28, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs