NCT02031536

Everolimus in Patients With Pancreatic Neuroendocrine Tumors Metastatic to the Liver Previously Treated With Surgery

A Randomized, Double-Blinded, Placebo-Controlled Phase II Study of Adjuvant Everolimus Following the Resection of Metastatic Pancreatic Neuroendocrine Tumors to the Liver

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well everolimus works in treating patients with pancreatic neuroendocrine tumors metastatic to the liver previously treated with surgery. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus after surgery may kill any tumors cells that remain.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate if the addition of adjuvant everolimus to the R0 or R1 surgical resection of pancreatic neuroendocrine tumor metastases to the liver will result in an improvement in disease free survival. SECONDARY OBJECTIVES: I. To evaluate if the addition of adjuvant everolimus to the R0 or R1 surgical resection of pancreatic neuroendocrine tumor metastases to the liver will result in an improvement in overall survival. II. To evaluate the toxicity associated with adjuvant everolimus following resection in patients with metastatic pancreatic neuroendocrine tumors to the liver. OUTLINE: Patients are randomized to 1 of 2 treatment arms in a 1:1 ratio. ARM A: Patients receive everolimus orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: 150 patients

Conditions

• Gastrinoma
• Glucagonoma
• Insulinoma
• Liver Metastases
• Pancreatic Polypeptide Tumor
• Recurrent Islet Cell Carcinoma
• Somatostatinoma

Interventions

Type	Name	Description
DRUG	everolimus	Given PO
OTHER	placebo	Given PO

Timeline

• Start date: 2014-04-10
• Primary completion: 2017-07-19
• Completion: 2017-07-19
• First posted: 2014-01-09
• Last updated: 2023-06-29
• Results posted: 2020-12-02

Locations

1 site across 1 country: United States