Docetaxel In Second-Line Treatment Of Advanced Non-Small-Cell Lung Cancer - The Distal Study
- Compare the quality of life of patients with stage IIIB or IV non-small cell lung
cancer treated with 2 different schedules of docetaxel as second-line therapy.
- Compare the toxicity of these regimens in these patients.
- Compare the response rate, time to progression, and survival of these patients treated
with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, ECOG performance status (0 vs 1 vs 2), response to prior chemotherapy (partial or
complete response vs stable disease vs progressive disease), and prior cisplatin-containing
chemotherapy regimen (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive docetaxel IV on day 1. Treatment continues every 3 weeks for a
maximum of 6 courses.
- Arm II: Patients receive docetaxel IV weekly for 6 weeks. Treatment continues every 8
weeks for a maximum of 2 courses.
Quality of life is assessed at baseline and days 22 and 43-56 for arm I, and at baseline and
days 22 and 43 for arm II.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Quality of life
Cesare Gridelli, MD
Istituto Nazionale per lo Studio e la Cura dei Tumori
United States: Federal Government