This phase I trial studies the side effects and best dose of fosbretabulin tromethamine and everolimus in treating patients with neuroendocrine tumors that have spread to other parts of the body or that cannot be removed by surgery. Fosbretabulin tromethamine may stop the growth of neuroendocrine tumors by blocking the blood vessels necessary for tumor growth. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving fosbretabulin tromethamine and everolimus may work better in treating patients with neuroendocrine tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT03014297.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To establish the maximum tolerated dose of the combination of everolimus and fosbretabulin tromethamine (fosbretabulin) in neuroendocrine tumors (grades 1-3) that have progressed after at least one prior regimen for metastatic disease.
SECONDARY OBJECTIVES:
I. To establish the safety profile of the combination of everolimus and fosbretabulin in this patient population.
II. To observe and record anti-tumor activity.
OUTLINE: This is a dose escalation study.
Patients receive fosbretabulin tromethamine intravenously (IV) over 10 minutes once per week or once every 3 weeks and everolimus orally (PO) daily. Courses with fosbretabulin tromethamine repeat every week or every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Treatment with everolimus continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorLowell Brian Anthony
