Cixutumumab, Everolimus, and Octreotide Acetate in Treating Patients With Advanced Low to Intermediate Grade Neuroendocrine Carcinoma

What Was Tested

In this phase 1 trial, researchers set out to test Octreotide.

Monoclonal antibodies, such as cixutumumab, may find tumor cells and help carry tumor-killing substances to them.

Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

It had 1 arm (groups): Treatment (cixutumumab, octreotide acetate, everolimus) (experimental).

Patients receive cixutumumab IV over 60-90 minutes and octreotide acetate IM on day 1 and everolimus PO QD on days 1-21. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

The registry classes the interventions as biological, drug and other.

More on the Plan

To evaluate the safety profile of IMC-A12 and everolimus with octreotide LAR.

To explore the anti-tumor activity of the combination of IMC-A12 and everolimus as defined by Response Evaluation Criteria in Solid Tumors (RECIST) response rate and progression-free survival (PFS).

To explore baseline molecular marker and drug-induced molecular marker changes that may predict clinical outcome.

Patients receive cixutumumab intravenously (IV) over 60-90 minutes and octreotide acetate intramuscularly (IM) on day 1 and everolimus orally (PO) once daily (QD) on days 1-21.

Who Took Part

Enrollment: 27 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: All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Zubrod performance status of 0 or 1. Leukocytes \> 3,000/mcL. Absolute neutrophil count \> 1,500/mcL. Platelets \> 100,000/mcL.

The full record lists 22 inclusion and 19 exclusion criteria; among the exclusions: patients may not be receiving any other investigational agents; uncontrolled intercurrent illness including, but not limited to:; ongoing or active infection requiring parenteral therapy at the time of study registration.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Octreotide study did not mask who received what.

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

It started in 2010-10 with completion listed for 2014-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Safety profile of cixutumumab and everolimus with octreotide acetate among patients with advanced neuroendocrine tumors, defined by the incidence of adverse events (time frame: Up to 30 days after completion of study treatment).

It also tracked 1 secondary outcome, for example Anti-tumor activity as determined by RECIST.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Octreotide in 27 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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