Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases
The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or radioembolization are considered "standard of care" regimens in patients with liver lesions from neuroendocrine tumors. However, the use of the combination of everolimus and radioembolization has not been formally evaluated in the setting of a clinical trial. Pasireotide is a medication that is intended to block the hormonal secretions from the neuroendocrine tumors.
This study is divided into two parts. In the first part, the aim of the study is to determine the safety of combining everolimus, pasireotide, and radioembolization. For this part of the study the investigators will enroll up to 18 patients. After the investigators confirm the safety of the combination, they will conduct the second part of the study which will focus on evaluating the effectiveness of the combination. For this part of the study the investigators intend to enroll a total of 37 patients.
Procedure: Sir-sphere Radioembolization
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase IB/II Study of Pasireotide, Everolimus and Selective Internal Radioembolization Therapy (SIRT) for Unresectable Neuroendocrine Hepatic Metastases|
- Evaluate the number of patients who develop side effects from combination therapy. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Determine the maximum tolerated dose of pasireotide and everolimus that can be administered with SIR Spheres. Patients will be treated in cohorts of three. Dose of everolimus will be increased after every three patients. Plan is to determine the maximum dose that can be administered with less than 2 out of 6 patients develop significant side effects.
- Compare the size of the tumor before and three months after treatment using cross sectional imaging (CT ro MRI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]To evaluate the response rate associated with the combination of pasireotide, everolimus and radioembolization. Response is defined as radiologic shrinkage in the size of the tumor.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Sir-sphere radioembolization
Everolimus, Pasireotide and Sir-sphere radioembolization
Pasireotide is given as an injection.
Other Name: Pasireotide other names are SOM230Procedure: Sir-sphere Radioembolization
A catheter will be placed in a branch of the hepatic artery (Liver) that supplies the tumor with blood. Radioactive beads will be injected into the tumor through the catheter.
Other Name: Sir-sphere RadioembolizationDrug: Everolimus
Given orally every day for the duration of the study
Other Name: Everolimus, RAD001
Liver metastasis remain a major challenge in the care of patients with Neuroendocrine Tumors (NET). This study is evaluating the combination of systemic therapies plus radioembolization for the treatment of liver metastasis from NET. The study allows pancreatic and intestinal NET that have spread to the liver.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469572
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Bassel El-Rayes, MD||Emory University Winship Cancer Institute|