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Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients

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: NCT00193323
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 28, 2010
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC

Brief Summary:
In this randomized trial, we attempt to further define optimal palliative chemotherapy for elderly patients with advanced non-small cell lung cancer by comparing single agent treatment with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Docetaxel Drug: Gemcitabine Phase 2

Detailed Description:

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

Docetaxel Docetaxel + Gemcitabine

For ever 2 patients treated, 1 will receive treatment A (docetaxel) and 1 will receive treatment B (Docetaxel + Gemcitabine). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : August 2001
Actual Primary Completion Date : May 2006
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. median survival
  2. one-year survival.

Secondary Outcome Measures :
  1. toxicity

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Biopsy-proven non-small cell lung cancer
  • No previous chemotherapy.
  • Age > 65 years
  • Age < 65 years requires significant assistance to perform activities of daily
  • Stage IV disease or stage IIIB disease
  • Ability to perform activities of daily living with minimal assistance
  • Measurable or evaluable disease
  • Adequate bone marrow, liver and kidney
  • All patients must sign written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Brain metastases
  • Meningeal metastases
  • Other uncontrolled malignancies
  • History of invasive cancer during the last 5 years
  • Moderate to severe peripheral neuropathy

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): NCT00193323

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United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
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Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC

Publications of Results:
Layout table for additonal information Identifier: NCT00193323     History of Changes
Other Study ID Numbers: SCRI LUN 52
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: June 28, 2010
Last Verified: January 2009

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