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

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
GlaxoSmithKline
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193362
First received: September 12, 2005
Last updated: July 27, 2010
Last verified: July 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

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
Study Completion Date: September 2007
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00193362     History of Changes
Other Study ID Numbers: SCRI LUN 54, B9E-MC-X338, VNR-R47
Study First Received: September 12, 2005
Last Updated: July 27, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Vinorelbine
Carboplatin
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on July 24, 2014