Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers

What Was Tested

The trial (phase 2) is built around Octreotide.

The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers.

The primary endpoint of this trial will be response rate.

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

Combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 43 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 biopsy-proven advanced, unresectable or metastatic, well-differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid, pancreatic islet cell and other well-differentiated neuroendocrine carcinomas. Patients with documented evidence of disease progression. Patients currently receiving or previously treated with single agent Sandostatin LAR® are eligible. Patients must have \>=1 unidimensional measurable lesion definable by. An ECOG Performance Status of 0-2.

The full record lists 19 inclusion and 25 exclusion criteria; among the exclusions: patients with poorly differentiated neuroendocrine carcinoma, highgrade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid, atypical carcinoid, anaplastic carcinoid, and small cell carcinoma are not eligible; previous treatment with vegf or egfr inhibitors; cytotoxic chemotherapy, immunotherapy or radiotherapy \<=4 weeks prior to study entry.

How the Study Was Run

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

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

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

It started in 2010-05 with completion listed for 2015-02.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Objective Response Rate (ORR) (time frame: 18 months).

It also tracked 4 secondary outcomes, for example Define Toxicity and Safety, Progression-Free Survival (PFS), Overall Survival (OS) and Disease Control Rate.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 43 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.