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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Everolimus — DRUG
  Given PO
• Octreotide Acetate — DRUG
  Given IM

Study Details

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.

Key Dates

First listed

Oct 28, 2010

Start date

Oct 15, 2010

Status verified

Aug 2022

Primary completion

Sep 1, 2014

Completion

Jan 3, 2018

Study Design

Enrollment

150 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (octreotide acetate and everolimus)
  Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28 and octreotide acetate 20 mg IM on day 1.
• Experimental: Arm II (octreotide acetate, everolimus, and bevacizumab)
  Patients receive 28-day cycles until progression or unacceptable toxicity consisting of: everolimus 10 mg PO QD on days 1-28, octreotide acetate 20 mg IM on day 1 and bevacizumab 10 mg/kg IV on days 1 and 15.

Primary Outcome Measure

Progression Free Survival [ Time Frame: From study entry to the date of documented progression or death from any cause, up to 3 years ]

Locations (388)

Find similar trials in Mobile, AL

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