Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Neuroendocrine Tumors

What Was Tested

This registered phase 2 trial tested Octreotide.

Well differentiated neuroendocrine (NE) carcinomas have low proliferative activity and conventional chemotherapy is not recommended.

Since well differentiated NE carcinomas are highly vascular, there is a rationale for testing metronomic chemotherapy and antiangiogenetic drugs.

It had 1 arm (groups): Drugs: bevacizumab + octreotide LAR + capecitabine (experimental).

Bevacizumab + octreotide + metronomic capecitabine.

The registry classes the interventions as drug.

More on the Plan

Patients with stable disease, complete or partial response will continue treatment until progressive disease or unacceptable toxicity.

Primary endpoint: the response to treatment, evaluated according to the RECIST criteria.

Who Took Part

Enrollment: 42 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Histologically or cytologically diagnosis of well-differentiated neuroendocrine carcinoma. Age \> 18. ECOG Performance Status 0-2. Life expectancy of at least 12 weeks. Measurable and/or evaluable lesions according to RECIST criteria.

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: serious non-healing wound or ulcer; evidence of bleeding diathesis or coagulopathy; uncontrolled hypertension.

How the Study Was Run

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

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 2006-01 with completion listed for 2009-05.

It ran at 5 sites in Italy (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: time to progression (time frame: 36 months).

It also tracked 3 secondary outcomes, for example Toxicity, Time to Treatment Failure (TTF) and Overall survival (OS).

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Octreotide in 42 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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