Lung Cancer
Conditions
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.
Interventions
DRUGDocetaxel
DRUGGemcitabine
Sponsors
Aventis Pharmaceuticals
SCRI Development Innovations, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median survival | — |
| one-year survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | — |
Countries
United States
Outcome results
None listed