Back to resultsWeekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility 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.
Sites / Locations
- Tennessee Oncology, PLLC
Outcomes
Primary Outcome Measures
median survival
one-year survival.
Secondary Outcome Measures
toxicity
Full Information
NCT ID
NCT00193323
First Posted
September 12, 2005
Last Updated
June 24, 2010
Sponsor
SCRI Development Innovations, LLC
Collaborators
Aventis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00193323
Brief Title
Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients
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 Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Aventis Pharmaceuticals
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
346 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Primary Outcome Measure Information:
Title
median survival
Title
one-year survival.
Secondary Outcome Measure Information:
Title
toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17823908
Citation
Hainsworth JD, Spigel DR, Farley C, Shipley DL, Bearden JD, Gandhi J, Ann Houston G, Anthony Greco F. Weekly docetaxel versus docetaxel/gemcitabine in the treatment of elderly or poor performance status patients with advanced nonsmall cell lung cancer: a randomized phase 3 trial of the Minnie Pearl Cancer Research Network. Cancer. 2007 Nov 1;110(9):2027-34. doi: 10.1002/cncr.23019.
Results Reference
result
Learn more about this trial
Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients
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