RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma

What Was Tested

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

It had 1 arm (groups): RAD001 plus Depot Octreotide (experimental).

The registry classes the interventions as drug.

More on the Plan

Octreotide Depot is FDA approved for the treatment of carcinoid syndrome and hormonal symptoms from certain islet cell carcinomas.

Octreotide Depot may also help to block certain proteins that are important in tumor growth.

Before you can start treatment on the study, you will have what are called "screening tests".

These tests will help the doctor decide if you are eligible to take part in the study.

Who Took Part

67 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 with histologic proof of low grade neuroendocrine carcinoma will be eligible. Both carcinoid (any site\[atypical/intermediate grade carcinoid is allowed\]) and islet cell (pancreatic endocrine tumor) will be eligible. Patients must have measurable disease, as defined by RECIST (Response Evaluation Criteria In Solid Tumors). Prior and concurrent octreotide (Sandostatin and Sandostatin LAR) is allowed. Prior radiation therapy is permitted. A recovery period of at least 4 weeks after completion of radiotherapy is required prior to enrollment. Patients may have received 0, 1, or 2 prior cytotoxic chemotherapy.

The full record lists 17 inclusion and 9 exclusion criteria; among the exclusions: patients may receive no other concurrent chemotherapy, immunotherapy, or radiotherapy; patients with intolerance to octreotide; patients who have received chemotherapy, immunotherapy, or investigational therapy in the 30 days prior to registration.

How the Study Was Run

Design: non-randomized, 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 2005-01 with completion listed for 2009-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Progression Free Survival (PFS) (time frame: PFS assessed every 12 weeks (at the end of every 3 cycles) or more frequently if clinically indicated).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Octreotide in 67 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.