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Monoclonal Antibodies

Octreotide + Interferon/Bevacizumab for Neuroendocrine Tumors

Phase 3

Waitlist Available

Led By James C Yao

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients not on anticoagulation must have prothrombin time (PT) and partial thromboplastin time (PTT) within specified limits

Patient must have unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

Study Summary

This trial is comparing two treatments for neuroendocrine tumors - octreotide acetate with either recombinant interferon alfa-2b or bevacizumab. The goal is to see if octreotide acetate with recombinant interferon alfa-2b is more effective than with bevacizumab.

Who is the study for?

This trial is for adults with advanced neuroendocrine tumors that can't be removed by surgery, are not just in the bones, and haven't spread to the brain. Participants should have a certain level of physical fitness (Zubrod status 0-2) and adequate organ function. They must not have had certain treatments like interferon or bevacizumab before, but one prior chemotherapy regimen is okay. Pregnant or breastfeeding individuals cannot join, and effective birth control is required for those who can conceive.Check my eligibility

What is being tested?

The study compares two treatments: octreotide acetate with recombinant interferon alfa-2b versus octreotide acetate with bevacizumab to see which is better at slowing down cancer growth in high-risk patients with metastatic or locally advanced neuroendocrine tumors.See study design

What are the potential side effects?

Possible side effects include irritation where the drug enters the body, flu-like symptoms from interferon such as fever and chills, hormonal changes due to octreotide, and increased risk of bleeding or blood clots from bevacizumab. Each treatment's side effects vary based on how it works.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood clotting tests are within normal ranges.

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My cancer cannot be removed by surgery and is a type of slow or moderately growing neuroendocrine tumor.

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My cancer has not spread to the bones only.

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I have not been treated with interferon, bevacizumab, or any drugs targeting VEGF.

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I have not had any other cancer types, except for certain allowed cases.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My pathology report identifies my cancer as a type of neuroendocrine tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Central Review-based Progression-Free Survival

Secondary outcome measures

Local Progression-Free Survival (Investigator Assessed)

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

Objective Response (Confirmed and Unconfirmed Complete Response and Partial Response)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (octreotide acetate and recombinant interferon alfa-2b)Experimental Treatment3 Interventions

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.

Group II: Arm I (octreotide acetate and bevacizumab)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5280

Octreotide Acetate

2016

Completed Phase 2

~260

Recombinant Interferon Alfa-2b

2019

Completed Phase 2

~150

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,932,726 Total Patients Enrolled

40 Trials studying Carcinoid Tumor

2,585 Patients Enrolled for Carcinoid Tumor

James C YaoPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00569127 — Phase 3

Carcinoid Tumor Research Study Groups: Arm I (octreotide acetate and bevacizumab), Arm II (octreotide acetate and recombinant interferon alfa-2b)

Carcinoid Tumor Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT00569127 — Phase 3

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00569127 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what afflictions is Bevacizumab most often prescribed?

"Bevacizumab has shown to be an effective treatment against malignant neoplasms, persistent cervical cancer, and recurrent cervical cancer."

Answered by AI

What other similar tests has Bevacizumab been involved in?

"The medication known as bevacizumab was first studied in 1997 at Vanderbilt University's Autonomic Dysfunction Center. As of now, there are 1848 completed studies and421 ongoing trials. Most of the active research is being conducted out of Lewes, Delaware."

Answered by AI

Are there many places in this city where patients can take part in this research?

"There are 100 sites associated with this clinical trial, making it one of the larger studies currently underway. The locations of these sites include Lewes, Jackson, Canton and other cities. If you are thinking about participating in this trial, please consider selecting a site near to minimize travel time and effort."

Answered by AI

Are there any open slots left for potential participants in this research?

"No, this particular trial is not currently seeking patients to enroll. Although the last update was on October 15th, 2022, the clinicaltrials.gov website shows that this study was first posted on December 1st, 2007. Having said that, there are nearly 3000 other trials with open enrollment at present."

Answered by AI

What is the margin of error for Bevacizumab?

"Bevacizumab has been evaluated for both its efficacy and safety in multiple Phase 3 trials, so it received a score of 3."

Answered by AI

How many people have signed up to participate in this experiment?

"This study is not currently recruiting patients. The clinical trial was first posted on December 1st, 2007 and updated October 15th, 2022. There are presently 2569 trials actively searching for patients with argentaffinoma and 421 trials for Bevacizumab that are looking for participants."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients with Advanced Carcinoid Tumors: SWOG S0518

Yao, James C., Katherine A. Guthrie, Cesar Moran, Jonathan R. Strosberg, Matthew H. Kulke, Jennifer A. Chan, Noelle LoConte, et al.. 2017. “Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients with Advanced Carcinoid Tumors: SWOG S0518”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2016.70.4072.

clinicaltrials.govStudy

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

2007. "Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00569127.

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