Octreotide + Interferon/Bevacizumab for Neuroendocrine Tumors
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.12345Why 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.26789
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 2-6 months.
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Octreotide Acetate
- Recombinant Interferon Alfa-2b
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor