Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.
- Determine the major objective response rate (partial response and complete response) in
patients with advanced bronchoalveolar cell non-small cell lung cancer treated with
- Assess the quality of life of patients treated with this regimen.
- Determine the duration of response and time to disease progression in patients treated
with this regimen.
- Determine the median survival of patients treated with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Major objective response rate (complete response and partial response)
Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions
At 4 weeks and then every 8 weeks
William Pao, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VCC THO 0214
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Northwestern Memorial Hospital||Chicago, Illinois 60611|