A Phase II Study of Single Agent Sorafenib in Non-small Cell Lung Cancer Patients Who Never Smoked or Were Former Light Smokers.
OBJECTIVES:
Primary
- To determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free
survival rate, in non-smokers or former light smokers with relapsed or refractory stage
IIIB or IV non-small cell lung cancer.
Secondary
- To determine the 1-year survival rate in patients treated with this drug.
- To assess the frequency and severity of adverse events associated with this drug in
these patients.
- To investigate the mutational status of EGFR (epidermal growth factor receptor), ALK
(anaplastic lymphoma kinase), ROS1, and K-Ras(Kirsten rat sarcoma viral oncogene
homolog)in archived tumor samples from these patients.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Archived tumor tissue samples are analyzed for mutations of EGFR, ALK, ROS1, and K-Ras by
PCR (polymerase chain reaction) and DNA (deoxyribonucleic acid) sequencing.
After completion of study treatment, patients are followed every 3 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival at 6 months
2008-present
No
Miguel A. Villalona, MD
Principal Investigator
Ohio State University
United States: Institutional Review Board
OSU-08017
NCT00754923
October 2008
Name | Location |
---|---|
Ohio State University | Columbus, Ohio 43210 |