Octreotide + Interferon/Bevacizumab for Neuroendocrine Tumors

Not currently recruiting at 570 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Must be taking: Octreotide

Must not be taking: Interferon, Bevacizumab

Disqualifiers: Brain tumor, Hypertension, Hemolytic anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 23

Duration: 21 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which combination of treatments—octreotide acetate with bevacizumab (a drug that inhibits blood vessel growth in tumors) or octreotide acetate with recombinant interferon alfa-2b (a protein that boosts the immune system)—is more effective for treating neuroendocrine tumors that have spread. Neuroendocrine tumors affect hormone-producing cells and can be difficult to treat once they spread. The trial seeks participants with high-risk tumors, meaning the tumors are growing despite treatment or causing severe symptoms like frequent flushing or bowel movements. Participants will receive either octreotide and bevacizumab or octreotide and recombinant interferon, aiming to slow or stop tumor growth. This study suits those who have tried other treatments without success and meet the specific tumor criteria. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not plan to use any other concurrent chemotherapy, immunotherapy, or certain other treatments while on the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that octreotide acetate, when combined with bevacizumab, is generally well-tolerated by patients. One study found that 16% of patients responded to these treatments, indicating some effectiveness without major safety issues.

Octreotide acetate is also used with recombinant interferon alfa-2b to treat neuroendocrine tumors, aiming to slow their growth. Although specific safety details for this combination aren't provided, octreotide acetate is commonly used in similar situations, suggesting it is usually well-tolerated.

This trial is in a later stage, indicating that earlier tests demonstrated these treatments to be safe enough for more extensive testing. Prospective participants should know that these treatments have been studied in humans before, and the trial is at a stage where safety is a primary focus. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for neuroendocrine tumors because they combine targeted therapies with different mechanisms of action. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, bevacizumab in Arm I specifically inhibits blood vessel growth that tumors need to thrive. Meanwhile, the combination in Arm II uses recombinant interferon alfa-2b to boost the immune system's natural cancer-fighting abilities. This multi-pronged approach not only targets the tumor directly but also enhances the body's own defenses, offering a potentially more effective and personalized treatment option.

What evidence suggests that this trial's treatments could be effective for neuroendocrine tumors?

Studies have shown that octreotide acetate can slow the growth of neuroendocrine tumor cells. In this trial, participants will receive different treatment combinations to evaluate their effectiveness. Arm I involves octreotide acetate combined with bevacizumab, a monoclonal antibody that research suggests might help prevent tumor cells from spreading. Arm II involves octreotide acetate combined with recombinant interferon alfa-2b, which has shown promise in stopping tumor growth and progression. Early findings suggest that these treatments together could be effective, but researchers are still determining the best combination. The current study aims to identify which treatment pairing better controls the disease. ^{2 6 7 8 9}

Who Is on the Research Team?

James C Yao

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My blood clotting tests are within normal ranges.

I have had treatments targeting specific cancer growth factors before.

Urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either depot octreotide plus bevacizumab or depot octreotide plus interferon. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

21 days per cycle

Visits every 21 days for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 2-6 months.

Up to 3 years

Follow-up visits every 2-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab
• Octreotide Acetate
• Recombinant Interferon Alfa-2b

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm II (octreotide acetate and recombinant interferon alfa-2b) Experimental Treatment 3 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 Treatment 3 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.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a phase 2 trial involving 50 patients with advanced neuroendocrine tumors (NETs), the combination of everolimus and octreotide LAR demonstrated an objective response rate of 18%, with 92% of patients achieving clinical benefit (complete response, partial response, or stable disease).

The treatment was generally well tolerated, with most adverse events being mild (grade 1 or 2), indicating that this combination therapy could be a safe and effective first-line option for patients with NETs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Everolimus in combination with octreotide long-acting repeatable in a first-line setting for patients with neuroendocrine tumors: an ITMO group study. Bajetta, E., Catena, L., Fazio, N., et al.[2015]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4323475/

Gastrointestinal neuroendocrine tumors treated with high ...

Eight studies reported expert clinical opinion that supported dose escalation of octreotide-LAR up to 60 mg/mo for symptom control and suggested increased doses ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00569127

Octreotide Acetate and Recombinant Interferon Alfa-2b or ...

Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5723116/

Octreotide long-acting repeatable in the treatment of ...

PROMID demonstrated for the first time long-term survival data in patients with metastatic midgut NETs, especially in those with low tumor ...

4.

stanfordhealthcare.org

stanfordhealthcare.org/trials/e/NCT01229943.html

Everolimus and Octreotide Acetate With or Without ...

Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor ...

5.

med.stanford.edu

med.stanford.edu/sleepdivision/research/clinicaltrials/results?ctid=NCT01229943&conditionId=&serviceLineId=&condition=&alpha=e

Clinical Trials results | Division of Sleep Medicine

Octreotide acetate may interfere with and slow the growth of tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27127841/

A Phase II Study of the Combination of Bevacizumab ...

Bevacizumab, pertuzumab, and octreotide depot was well-tolerated with a 16% ORR. Results in the well-differentiated carcinoid tumors are ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5983100/

A Review of its Use in Treating Neuroendocrine Tumours

Pooled data from more than 14 trials including almost 400 patients revealed that 71 % of patients with GEP-NETs and carcinoid syndrome experience resolution or ...

8.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT01121939?keyword=%22Octreotide%22

San Mateo Clinical Trial Combination of Bevacizumab ...

To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and ...

9.

wjgnet.com

wjgnet.com/1007-9327/full/v21/i6/1945.htm

Gastrointestinal neuroendocrine tumors treated with high ...

Studies that reported data on efficacy and safety of ≥ 30 mg/mo octreotide-LAR for NETs in human subjects, published in any language were included in the review ...