Sorafenib in Treating Patients With Refractory Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
RATIONALE: Preclinical studies indicate that sorafenib is a potent inhibitor of Raf kinase in
vitro and in vivo, with significant dose-dependent, anti-tumor activity in four different
human tumor types including colon, pancreatic, lung, and ovarian. This activity was
cytostatic in nature and was maintained if dosing was continued. That is, tumor growth is
suspended while the drug is administered but returns to baseline rates when the agent is
withdrawn. Therefore, the optimal schedule will be an uninterrupted one. To assess the
activity of sorafenib in a timely manner and with a meaningful interpretation, a randomized
discontinuation design was adopted in the present trial, conducted in a population who were
potentially sensitive to sorafenib.
PURPOSE: This randomized phase II trial is studying sorafenib to see how well it works
compared to placebo in treating patients with refractory non-small cell lung cancer.