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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

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Central Review-based Progression-Free Survival
Secondary study objectives
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
~5540
Octreotide Acetate
2016
Completed Phase 2
~260
Recombinant Interferon Alfa-2b
2019
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,573 Total Patients Enrolled
81 Trials studying Neuroendocrine Tumors
43,291 Patients Enrolled for Neuroendocrine Tumors
James C YaoPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT00569127 — Phase 3
Neuroendocrine Tumors Research Study Groups: Arm I (octreotide acetate and bevacizumab), Arm II (octreotide acetate and recombinant interferon alfa-2b)
Neuroendocrine Tumors 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
~24 spots leftby Sep 2025
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