Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.
OBJECTIVES:
Primary
- Determine the major objective response rate (partial response and complete response) in
patients with advanced bronchoalveolar cell non-small cell lung cancer treated with
erlotinib hydrochloride.
Secondary
- 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
unacceptable toxicity.
Interventional
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
No
William Pao, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VCC THO 0214
NCT00416650
July 2002
March 2013
Name | Location |
---|---|
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 |