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RATIONALE: Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving sorafenib tosylate together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of everolimus when given together with sorafenib tosylate and to see how well they work 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
sorafenib tosylate, everolimus, laboratory biomarker analysis, pharmacogenomic studies, pharmacological study, mass spectrometry, liquid chromatography, polymorphism analysis, polymerase chain reaction
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Published on BioPortfolio: 2014-08-27T03:19:11-0400
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Works consisting of studies using a quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc. It is often an overview of clinical trials. It is usually called a meta-analysis by the author or sponsoring body and should be differentiated from reviews of literature.
The detection of genetic variability (e.g., PHARMACOGENOMIC VARIANTS) relevant to PHARMACOGENETICS and PRECISION MEDICINE. The purpose of such genetic testing is to help determine the most effective treatment options and their optimum dosages with least potential risks for DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS.
The application of discoveries generated by laboratory research and preclinical studies to the development of clinical trials and studies in humans. A second area of translational research concerns enhancing the adoption of best practices
A quantitative method of combining the results of independent studies (usually drawn from the published literature) and synthesizing summaries and conclusions which may be used to evaluate therapeutic effectiveness, plan new studies, etc., with application chiefly in the areas of research and medicine.
The application of discoveries generated by laboratory research and preclinical studies to the development of clinical trials and studies in humans. A second area of translational research concerns enhancing the adoption of best practices.
Pancreatitis Acute pancreatitis is inflammation of the pancreas caused by the release of activated pancreatic enzymes. Common triggers are biliary tract disease and chronic heavy alcohol intake. Diagnosis is based on clinical presentation...
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