Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
- Determine the response rate in patients with inoperable stage IIIB or IV non-small cell
lung cancer treated with gemcitabine and docetaxel.
- Determine the progression-free and overall survival of patients treated with this
- Determine the tolerance profile of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1.
Treatment repeats every 15 days for up to 12 courses in the absence of disease progression
or unacceptable toxicity.
Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Masking: Open Label, Primary Purpose: Treatment
Philippe Terrioux, MD
Clinique de Docteur Terrioux
United States: Federal Government