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

  • STATUS
    Not Recruiting
  • participants needed
    25
  • sponsor
    SCRI Development Innovations, LLC
Updated on 10 November 2021
ct scan
renal function
cancer
carcinoma
lanreotide
metastasis
liver metastasis
liver metastases
metastatic cancer
neuroendocrine carcinoma
renal function test
neuroendocrine tumor
radioembolization
neuroendocrine tumors
carcinoid tumor
islet cell carcinoma

Summary

Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide (Somatuline Depot) Injection and Yttrium-90 microspheres (SIR-Spheres) each have FDA approval to treat patients with metastatic NETs. The purpose of this study is to determine if treatment for patients with NETs can be optimized by combining these therapies.

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 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.

Details
Condition Gastrointestinal Neoplasm, Neuroendocrine Tumor, Carcinoid Tumor
Treatment Lanreotide, Y-90 microspheres
Clinical Study IdentifierNCT02859064
SponsorSCRI Development Innovations, LLC
Last Modified on10 November 2021

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