A Multicenter, Randomized Phase II Study of Two Schedules of Taxotere (Weekly Versus Every 3 Weeks) in Elderly or Poor Performance (ECOG PS 2), Chemotherapy-Naive Patients With Advanced Non-Small Cell Lung Cancer
- Compare the effects of two different schedules of docetaxel on the incidence of grade 3
and 4 toxic effects in older or poor performance chemotherapy-naïve patients with
unresectable stage IIIB or IV non-small cell lung cancer.
- Compare the overall survival of patients treated with these regimens.
- Compare the response rate in patients treated with these regimens.
- Compare the incidence of serious adverse events in patients treated with these
- Determine the quality of life of patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21
days in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Treatment
repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 2 courses during study treatment, and then at
Patients are followed at 1 month and then every 2-3 months thereafter.
PROJECTED ACCRUAL: A total of 210-230 patients (105-115 per treatment arm) will be accrued
for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Afshin Dowlati, MD
Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|