Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

What Was Tested

This registered phase 3 trial tested Octreotide.

This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced).

Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread.

It had two arms (groups): Arm I (octreotide acetate and bevacizumab) (experimental) and Arm II (octreotide acetate and recombinant interferon alfa-2b) (experimental).

Patients receive depot octreotide acetate IM and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive octreotide acetate IM as in arm I on day 1 and recombinant interferon alfa-2b SC on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

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

More on the Plan

To compare central review-based progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide (octreotide acetate) plus bevacizumab, or depot octreotide plus interferon (recombinant interferon alfa-2b).

To compare overall survival, time to treatment failure and traditionally reported progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon.

To compare objective response (confirmed and unconfirmed complete response \[CR\] and partial response \[PR\]) in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon.

To compare the toxicity profile of patients treated with these two regimens.

Who Took Part

427 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Patient must have unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma. Occasionally, it is not possible to establish tumor grade on fine-needle aspiration (FNA) cytology material; if a new biopsy is needed, a core needle biopsy should be obtained whenever possible. Patient must have high risk disease as defined by at least one of the following:. Refractory carcinoid syndrome while receiving octreotide (defined by \> 2 flushing episodes/day or \> 4 bowel movements/day). Atypical histology and more than 6 lesions.

The full record lists 48 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2007-12-01 with completion listed for 2015-01-01.

It ran at 493 sites in United States (493).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Central Review-based Progression-Free Survival (time frame: Up to 3 years).

It also tracked 5 secondary outcomes, for example Overall Survival, Time to Treatment Failure, Local Progression-Free Survival (Investigator Assessed), Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response) and Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 427 people.

Its status is active not recruiting; results are posted on the registry, and this page does not restate them.

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