Status:
COMPLETED
Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 doc...
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 (docetax...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2009
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT00193323
Start Date
August 1 2001
End Date
January 1 2009
Last Update
June 28 2010
Active Locations (1)
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1
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023