A Phase II Study of Taxotere and Gemcitabine for Stages III-B and IV Non-Small Cell Lung Cancer
- Determine the response rate of patients with recurrent stage IIIB and IV non-small cell
lung cancer treated with gemcitabine hydrochloride and docetaxel.
- Determine the overall and progression-free survival of patients treated with this
- Determine the toxic effects of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
OUTLINE: Patients receive gemcitabine hydrochloride IV over 30 minutes followed by docetaxel
IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
patient response rate to weekly taxotere and gemcitabine
Antonius A. Miller, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board