Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres

Summary

Participation Requirements

Description

This is an open-label, prospective, multi-center Phase II study for patients with metastatic well-to-moderately differentiated neuroendocrine tumors, including typical carcinoid and pancreatic neuroendocrine tumors, who are candidates for liver-directed radioembolization. Lanreotide (Somatuline® Dep...

This is an open-label, prospective, multi-center Phase II study for patients with metastatic well-to-moderately differentiated neuroendocrine tumors, including typical carcinoid and pancreatic neuroendocrine tumors, who are candidates for liver-directed radioembolization. Lanreotide (Somatuline® Depot) Injection, is FDA-approved for treating unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroentero-pancreatic neuro-endocrine tumors (GEP-NETs) to improve progression-free survival. Radioembolization with yttrium-90 microspheres (SIR-Spheres® therapy) is FDA-approved for treating liver metastases from colorectal cancer. While each of these individual treatments has had promising results, investigators hypothesize that treatment for patients with NETs can be optimized by co-administration of both therapies. Patients will receive treatment with lanreotide (120 mg subcutaneously every 28 days) in combination with SIR-Spheres therapy. The dose and treatment day of SIR-Spheres will be determined by the treating radiation oncologist. Patients who are currently receiving or have previously received lanreotide are eligible, and treatment with lanreotide can continue monthly until disease progression or unacceptable toxicity. Up to 25 patients are planned for enrollment to be conducted at approximately 5 investigational sites in the U.S.

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