Everolimus and Octreotide Acetate With or Without Bevacizumab in Treating Patients With Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumors That Cannot Be Removed by Surgery

NCT01229943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-08-04

Study results available
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Summary

This randomized phase II trial studies how well everolimus and octreotide acetate with or without bevacizumab works in treating patients with pancreatic neuroendocrine tumors that cannot be removed by surgery and have spread nearby or to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and everolimus also may stop the growth of pancreatic neuroendocrine tumors by blocking blood flow to the tumor. It is not yet known whether giving everolimus and octreotide acetate together is more effective with or without bevacizumab in treating pancreatic neuroendocrine tumors.

Conditions

  • Advanced Pancreatic Neuroendocrine Tumor
  • Locally Advanced Pancreatic Neuroendocrine Tumor
  • Pancreatic Gastrinoma
  • Pancreatic Neuroendocrine Tumor G1
  • Pancreatic Neuroendocrine Tumor G2
  • Pancreatic Vipoma

Interventions

BIOLOGICAL

Bevacizumab

Given IV

DRUG

Everolimus

Given PO

DRUG

Octreotide Acetate

Given IM

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Matthew H Kulke · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-15
Primary Completion
2014-09-01
Completion
2018-01-03

Countries

  • United States
  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01229943 on ClinicalTrials.gov