Randomized Phase II Study of First-Line Treatment With Gemcitabine vs. Erlotinib vs. Gemcitabine and Erlotinib in Elderly Patients With Stage IIIB/IV Non-Small Cell Lung Cancer
- Compare the progression-free survival rate of older patients with stage IIIB or IV
non-small cell lung cancer treated with gemcitabine hydrochloride vs erlotinib
hydrochloride vs gemcitabine hydrochloride and erlotinib hydrochloride as first-line
- Determine the response rate in patients receiving these regimens.
- Determine the overall survival rate in patients receiving these regimens.
- Determine the toxicity profile of these regimens in these patients.
- Determine the quality of life of patients receiving these regimens.
OUTLINE: This is a randomized, open-label, controlled, parallel group, multicenter study.
Patients are stratified by gender, smoking status (never or light vs current or former), and
ECOG performance status (0-1 vs 2). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV on days 1 and 8. Patients with
progressive disease may cross over to arm II.
- Arm II: Patients receive oral erlotinib hydrochloride daily on days 1-21.
- Arm III: Patients receive gemcitabine hydrochloride as in arm I and erlotinib
hydrochloride as in arm II.
In all arms, treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 2 months for 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant
Thomas E Stinchcombe, MD
UNC Lineberger Comprehensive Cancer Center
United States: Food and Drug Administration
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Hackensack University Medical Center Cancer Center||Hackensack, New Jersey 07601|
|Batte Cancer Center at Northeast Medical Center||Concord, North Carolina 28025|
|Evanston Hospital||Evanston, Illinois 60201-1781|
|Highlands Oncology Group - Fayetteville||Fayetteville, Arkansas 72703|
|Rex Cancer Center at Rex Hospital||Raleigh, North Carolina 27607|
|University of Tennessee Cancer Institute - Memphis||Memphis, Tennessee 38104|
|Cape Fear Valley Medical Center Cancer Center||Fayetteville, North Carolina 28302-2000|
|Summit Cancer Care||Savannah, Georgia 31405|
|Kingsport Hematology-Oncology Associates||Kingsport, Tennessee 37660|