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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

Pivotal Trial

No Placebo-Only Group

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 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

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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