Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy

What Was Tested

This registered phase 2 trial tested Octreotide.

All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy.

Who Took Part

160 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: Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET). Confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Presence of at least one measurable disease using RECIST criteria at screening (computer tomography \[CT\] or Magnetic resonance imaging \[MRI\]). Adequate bone marrow, liver and kidney function. WHO Performance Status 0-2.

The full record lists 9 inclusion and 6 exclusion criteria; among the exclusions: anticancer therapy within 3 weeks of enrollment; patients with poorly differentiated neuroendocrine carcinoma; hepatic artery embolization within the last 6 months.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-06 with completion listed for 2008-01.

It ran at 54 sites in United States (20), Germany (7), France (6), Canada (5), Italy (5) and Australia (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST).

It also tracked 11 secondary outcomes, for example Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review, Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review, Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1), Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2), Time to Overall Survival (OS)(Stratum 1) and Time to Overall Survival (OS) (Stratum 2).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 160 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.