Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Yonsei University
OBJECTIVES: Primary * To assess the response rate of sorafenib tosylate in combination with erlotinib hydrochloride in patients with stage IIIB-IV non-small cell lung cancer refractory to 1 or 2 prior chemotherapy regimens. Secondary * To assess the response duration in patients treated with this regimen. * To assess the disease control rate in patients treated with this regimen. * To assess the progression-free survival of patients treated with this regimen. * To assess the overall survival of patients treated with this regimen. * To assess the safety and tolerability of this regimen in these patients. * To analyze biomarkers, including evaluation of EGFR expression, mutational analysis of EGFR and K-ras, and immunohistochemical analysis of EGFR downstream pathway (phospho-EGFR, phospho-AKT, phospho-Erk, phospho-STAT3). OUTLINE: This is a multicenter study. Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Tissue samples are analyzed at the nucleic acid level for EGFR mutation (exon 18-21) and K-ras mutation (exon 2), DNA mutations via PCR, presence of EGFR protein by IHC, and downstream effectors of EGFR activation by IHC. After completion of study therapy, patients are followed periodically.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
