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

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide.

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.

It had two arms (groups): Arm I (octreotide acetate and everolimus) (experimental) and Arm II (octreotide acetate, everolimus, and bevacizumab) (experimental).

The registry classes the interventions as biological and drug.

More on the Plan

To assess the progression-free survival rate of patients with locally advanced or metastatic pancreatic neuroendocrine tumors treated with everolimus alone or everolimus plus bevacizumab.

To estimate the overall tumor response rate in patients with metastatic pancreatic neuroendocrine tumors treated with one of two novel regimens.

To estimate the overall biochemical response rate (as measured by plasma chromogranin A levels) in patients with metastatic pancreatic neuroendocrine tumors treated with these regimens.

To assess the toxicity of each regimen in patients with metastatic pancreatic neuroendocrine tumors.

Who Took Part

The registry lists 150 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients must have histologic documentation of well-differentiated or moderately differentiated neuroendocrine tumor from either a primary or metastatic site. If different histologic classification schemes are used, equivalent histologic classifications (for example "grade 1", "low-grade", or "intermediate-grade") are allowed. Patients with poorly differentiated neuroendocrine carcinoma or small cell carcinoma are excluded. Documentation from a metastatic disease site is sufficient if there is clinical evidence of a pancreatic primary site. Locally unresectable or metastatic disease.

The full record lists 56 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Octreotide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2010-10-15 with completion listed for 2014-09-01.

It ran at 394 sites in United States (388) and Canada (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression Free Survival.

It also tracked 2 secondary outcomes, for example Overall Response Rate and Overall Survival (OS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 150 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.