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

NCT02859064 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: SCRI GI 221
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Neuroendocrine Tumors; Gastrointestinal Neoplasms; Carcinoid Tumors

Keywords

radioembolization; somatostatin analogs; carcinoid; neuroendocrine; liver-directed therapy

Outcome Measures

Primary Outcomes (1)

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

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

  From the day of the first dose to 30 days after the last dose of study medication, up to 52 months

Secondary Outcomes (4)

• Overall Response Rate

  At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months

• Disease Control Rate

  At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months.

• Progression Free Survival

  At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months

• Overall Survival

  At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, up to 52 months

Study Arms (1)

Lanreotide/Y-90 microspheres

EXPERIMENTAL

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.

Drug: Lanreotide; Device: Y-90 microspheres

Interventions

Lanreotide DRUG

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.

Also known as: Somatuline® Depot Injection

Lanreotide/Y-90 microspheres

Y-90 microspheres DEVICE

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

Also known as: SIR-Spheres

Lanreotide/Y-90 microspheres

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic well-to-moderately differentiated (or low-grade) neuroendocrine carcinoma, including typical carcinoid or pancreatic islet cell carcinoma.
• Computerized tomography (CT) scan evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent at the time of study entry. If a CT scan is not possible, then an MRI may be used.
• Patients who are currently receiving or have previously received lanreotide or another somatostatin analogue are eligible. Previous treatment with lanreotide or another somatostatin analogue is not required for study entry.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Adequate hematologic, hepatic and renal function.
• Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 3 months (90 days) following last dose of study drug(s). Male patients must also refrain from donating sperm during their participation in the study and for 3 months after last dose of study drug(s).
• Life expectancy ≥ 3 months.
• Willingness and ability to comply with study and follow-up procedures.
• Ability to understand the nature of this study and give written informed consent.

You may not qualify if:

• Anti-cancer therapy with the exception of lanreotide or another somatostatin analogue within 21 days or 5 half-lives (whichever is shorter) of starting study treatment.
• Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to Cycle 1 Day 1 or has not recovered from side effects of such therapy.
• Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
• Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
• Clinically significant ascites, cirrhosis, portal hypertension, or thrombosis as determined by clinical or radiologic assessment.
• Pregnant or lactating.
• Acute or chronic liver, renal, or pancreas disease.
• Any of the following cardiac diseases currently or within the last 6 months:
• Left Ventricular Ejection Fraction (LVEF) \<45% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO)
• QTc interval \>480 ms on screening electrocardiogram (ECG)
• Unstable angina pectoris
• Congestive heart failure (New York Heart Association (NYHA) ≥ Grade 2
• Acute myocardial infarction
• Conduction abnormality not controlled with pacemaker or medication
• Significant ventricular or supraventricular arrhythmias (patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Ipsen: collaborator

Study Sites (3)

Rocky Mountain Cancer Center

Denver, Colorado, 80218, United States

Location

Research Medical Center/HCA Midwest

Kansas City, Missouri, 64132, United States

Location

Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Gastrointestinal Neoplasms; Carcinoid Tumor

Interventions

lanreotide

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Results Point of Contact

• Title: Sarah Cannon Development Innovations, LLC
• Organization: Sarah Cannon Development Innovations, LLC

CANN.InnovationsMedical@sarahcannon.com

844-710-6157

Study Officials

• David Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 8, 2016
• Study Start: July 28, 2017
• Primary Completion: May 27, 2022
• Study Completion: June 10, 2022
• Last Updated: December 5, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)