Gemcitabine and/or Erlotinib as First-Line Therapy in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

- 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
therapy.

Secondary

- 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.