Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres
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|ClinicalTrials.gov Identifier: NCT02859064|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2016
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Gastrointestinal Neoplasms Carcinoid Tumors||Drug: Lanreotide Device: Y-90 microspheres||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres (SIR-Spheres®)|
|Actual Study Start Date :||July 28, 2017|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: Lanreotide/Y-90 microspheres
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.
Other Name: Somatuline® Depot Injection
Device: Y-90 microspheres
To be administered by injection through a trans-femoral catheter into the hepatic artery.
Other Name: SIR-Spheres
- Number of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as a measure of safety [ Time Frame: every cycle (28 days) until disease progression or unacceptable toxicity, projected up to 1 year ]The incidence of AEs and SAEs for all patients who receive at least 1 dose of both study medications will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
- Overall Response Rate [ Time Frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, projected 1 year. ]Proportion of patients with confirmed complete or partial response (CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- Disease Control Rate [ Time Frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, projected 1 year. ]Proportion of patients with CR, PR or stable disease (SD) according to RECIST v1.1.
- Progression Free Survival [ Time Frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, projected 1 year. ]The time from Day 1 of study drug administration to disease progression as defined by RECIST v1.1, or death on study.
- Overall Survival [ Time Frame: At 12 weeks post-treatment with SIR-Spheres then every 8 weeks, projected 1 year. ]The time from Day 1 of study drug administration until death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859064
|United States, Colorado|
|Rocky Mountain Cancer Center|
|Denver, Colorado, United States, 80218|
|United States, Missouri|
|Research Medical Center/HCA Midwest|
|Kansas City, Missouri, United States, 64132|
|United States, Tennessee|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Johanna C. Bendell, M.D.||SCRI Development Innovations, LLC|