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 at http://cancer.gov/clinicaltrials/SWOG-S0518.

Principal Investigator
Dr. James Yao, Southwest
Oncology Group

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. Carcinoid tumors tend to produce a lot of blood vessels and may be susceptible to antiangiogenesis therapy.

The monoclonal antibody bevacizumab (Avastin) 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 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 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 at http://cancer.gov/clinicaltrials/SWOG-S0518 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.