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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193323
First received: September 12, 2005
Last updated: June 24, 2010
Last verified: January 2009
  Purpose

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 Intervention Phase
Lung Cancer
Drug: Docetaxel
Drug: Gemcitabine
Phase 2

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • median survival
  • one-year survival.

Secondary Outcome Measures:
  • toxicity

Estimated Enrollment: 346
Study Start Date: August 2001
Study Completion Date: January 2009
Primary Completion Date: May 2006 (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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  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: NCT00193323

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00193323     History of Changes
Other Study ID Numbers: SCRI LUN 52, 104864-450
Study First Received: September 12, 2005
Last Updated: June 24, 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
Docetaxel
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

ClinicalTrials.gov processed this record on July 29, 2014