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

June 24, 2010 updated by: SCRI Development Innovations, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

346

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37023
        • Tennessee Oncology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
median survival
one-year survival.

Secondary Outcome Measures

Outcome Measure
toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCRI Development Innovations, LLC

Collaborators

Aventis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

June 28, 2010

Last Update Submitted That Met QC Criteria

June 24, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCRI LUN 52
  • 104864-450

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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