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

2014-08-27 03:19:11 | BioPortfolio

Summary

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.

Description

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pancreatic Cancer

Intervention

sorafenib tosylate, everolimus, laboratory biomarker analysis, pharmacogenomic studies, pharmacological study, mass spectrometry, liquid chromatography, polymorphism analysis, polymerase chain reaction

Location

Roswell Park Cancer Institute
Buffalo
New York
United States
14263

Status

Recruiting

Source

Roswell Park Cancer Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:11-0400

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