A Phase III Study of Delayed vs. Immediate Second-Line Therapy With Docetaxel After Gemcitabine + Carboplatin in Advanced Non-Small Cell Lung Cancer
- Compare the overall survival of patients with stage IIIB or IV non-small cell lung
cancer treated with gemcitabine and carboplatin followed by immediate vs delayed
- Compare the response rate and time to progression in patients treated with these
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to ECOG performance
status (0 or 1 vs 2).
All patients receive gemcitabine IV over 30-60 minutes on days 1 and 8 and carboplatin IV
over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.
Patients with stable or responding disease proceed to docetaxel therapy. Patients are
randomized to 1 of 2 treatment arms.
- Arm I (immediate docetaxel): Patients receive immediate docetaxel IV over 1 hour on day
- Arm II (delayed docetaxel): Patients are observed until first evidence of disease
progression and then receive docetaxel IV over 1 hour on day 1.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life (QOL) is assessed at baseline, at restaging (after completion of gemcitabine
and carboplatin), before courses 2-6 of docetaxel*, and then at 1 and 3 months after study
NOTE: *For patients randomized to delayed docetaxel, QOL is assessed every 3 weeks until
first disease progression and then before courses 2-6 of docetaxel
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3
PROJECTED ACCRUAL: A total of 550 patients (275 per treatment arm) will be accrued for this
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter
Nathan Levitan, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|