Sorafenib Tosylate and Everolimus in Treating Patients With Advanced Solid Tumors and Metastatic Pancreatic Cancer That Does Not Respond to Gemcitabine Hydrochloride

PRIMARY OBJECTIVES: I. To determine the 6-month overall survival of patients with previously
treated gemcitabine-refractory metastatic pancreatic cancer treated with the combination of
sorafenib and everolimus. II. To determine the recommended Phase II dose of everolimus when
administered in combination with sorafenib in patients with advanced solid tumors.
SECONDARY OBJECTIVES: I. To determine the response rate, median survival, time to
progression, CA 19.9 decline and toxicity spectrum of the combination in this patient
population. II. To characterize the pharmacokinetic profiles of sorafenib and everolimus
when given in combination. III. To explore the biomarkers that correlate with response to
the study combination in patients previously treated with gemcitabine-refractory metastatic
pancreas cancer. OUTLINE: This is a phase I, dose-escalation study of everolimus, followed
by a phase II study. Patients receive oral everolimus 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. After completion of study treatment, patients are
followed every 3 months for up to 1 year.