Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Neuroendocrine Tumors

Gastrointestinal Neoplasms

Digestive System Neoplasms

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Gastrointestinal Diseases

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Hematinics

Antineoplastic Agents

Somatostatin

Liver Extracts

Lanreotide

Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.

Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.

Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.

To be administered by injection through a trans-femoral catheter into the hepatic artery.

Y-90 microspheres

David Spigel, M.D.

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.

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.

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

A Phase II Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres (SIR-Spheres®)

Treatment-emergent Adverse Events were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Percentage of patients with confirmed complete or partial response (CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.

Percentage of patients with CR, PR or stable disease (SD) according to RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1),: Complete Response (CR): Disappearance of all target and non-target lesions; Partial Response (PR): \>=30% decrease in the sum of the diameters of target lesions; Stable Disease: Meeting neither criteria for PR or Progression (PD= greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions). Disease Control Rate (DCR) = CR + PR + SD.

The time from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study. Per RECIST V1.1 criteria, progression is defined as a greater than 20% increase in the sum of diameters of target lesions, or an unequivocal increase in a non-target lesion, or the appearance of new lesions.

The time from Day 1 of study drug administration until death from any cause.

Ipsen

SCRI Development Innovations, LLC

All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Lanreotide: 120 mg by subcutaneous injection (SQ) on Day 1 of every cycle (every 28 days) in combination with SIR-Spheres therapy.

Y-90 (Yttrium-90) microspheres \[SIR-Spheres therapy\]: dose and treatment day to be determined by treating radiation oncologist.

Lanreotide: Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.

Y-90 microspheres: To be administered by injection through a trans-femoral catheter into the hepatic artery.

Lanreotide/Y-90 Microspheres

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

All patients who received at least one dose of treatment of lanreotide and Y-90 microspheres.

Sarah Cannon Development Innovations, LLC

All enrolled patients who received at least one dose of both study medications, at least one dose of lanreotide and at least one dose of Y-90 microspheres.

Number of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability

All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres

Overall Response Rate

All enrolled patients who received at least one full dose of lanreotide and y-90 microspheres.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres	NCT02859064	Neuroendocrine ... Gastrointestina... Carcinoid Tumor...	Lanreotide Y-90 microspher...	18 Years -	SCRI Development Innovations, LLC
Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres	NCT02859064	Neuroendocrine ... Gastrointestina... Carcinoid Tumor...	Lanreotide Y-90 microspher...	18 Years -	SCRI Development Innovations, LLC

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