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Name of the Trial

Phase III Randomized Study of Depot Octreotide Acetate and Interferon alfa-2b Versus Depot Octreotide Acetate and Bevacizumab in Patients With Unresectable Metastatic or Locally Advanced, High-Risk Neuroendocrine Carcinoid Tumor (SWOG-S0518). See the protocol summary ³.

Principal Investigators

Dr. James Yao, Southwest Oncology Group.

Dr. James Yao Principal Investigator

Why This Trial Is Important

Carcinoid tumors originate most often in neuroendocrine cells of the gastrointestinal tract, although they can arise elsewhere in the body. While most carcinoid tumors grow slowly, they are often resistant to treatment and can be life threatening when advanced. Currently, there is no treatment that has been proven to stop or slow the growth of advanced carcinoid tumors, and patients with these tumors face a dim prognosis.

Doctors are eager to find new ways to treat advanced carcinoid tumors. One strategy being studied is the inhibition of tumor angiogenesis, the growth of new blood vessels that tumors need to keep growing. Carcinoid tumors tend to produce a lot of blood vessels and may be susceptible to antiangiogenesis therapy.

The monoclonal antibody bevacizumab ⁴ has been shown to inhibit tumor angiogenesis and is approved by the FDA to treat several different cancer types. In this trial, patients with advanced carcinoid tumors that have spread (metastasized) or that cannot be surgically removed (unresectable) will be randomly assigned to receive the drug octreotide acetate along with either bevacizumab or another drug called interferon alfa. The combination of octreotide acetate and interferon alfa is often used for refractory carcinoid syndrome, a collection of symptoms, including flushing, abdominal pain, and diarrhea, caused by hormones secreted by advanced carcinoid tumors.

"In our previous phase II study comparing these combinations, the addition of bevacizumab to octreotide acetate led to rapid and sustained decreases in tumor blood flow, resulting in disease stabilization in most patients who received it and even producing partial responses in some patients," said Dr. Yao. "Additionally, patients receiving bevacizumab were more likely to have stable disease at 18 weeks than patients who received interferon.

"With this phase III trial, we hope to confirm these results and possibly establish bevacizumab as a standard therapy for patients with these difficult to treat tumors."

For More Information

See the lists of entry criteria and trial contact information ³ at or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

Glossary Terms

Cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment.

A slow-growing type of tumor usually found in the gastrointestinal system (most often in the appendix), and sometimes in the lungs or other sites. Carcinoid tumors may spread to the liver or other sites in the body, and they may secrete substances such as serotonin or prostaglandins, causing carcinoid syndrome.

The stomach and intestines. The gastrointestinal tract is part of the digestive system, which also includes the salivary glands, mouth, esophagus, liver, pancreas, gallbladder, and rectum.

A biological response modifier (a substance that can improve the body's natural response to infections and other diseases). Interferons interfere with the division of cancer cells and can slow tumor growth. There are several types of interferons, including interferon-alpha, -beta, and -gamma. The body normally produces these substances. They are also made in the laboratory to treat cancer and other diseases.

Having to do with the interactions between the nervous system and the endocrine system. Neuroendocrine describes certain cells that release hormones into the blood in response to stimulation of the nervous system.

A drug similar to the naturally occurring growth hormone inhibitor somatostatin. Octreotide is used to treat diarrhea and flushing associated with certain types of tumors.