Excel Diagnostics and Nuclear Oncology Center in Houston, Texas, is the first center in the United States to start recruiting patients in a multicenter randomized clinical trial of Lu-177 Octreotate in patients with progressive midgut carcinoid. This is a Phase III trial for Lutathera®, the first theragnostic drug in Molecular Nuclear Medicine (MNM) to enter phase III clinical development. Dr. Ebrahim S. Delpassand, Principal Investigator and Chairman and Medical Director of Excel Diagnostics, announced that the first patient in this trial is expected to be enrolled this month.
This international study has already begun in Europe, with the first European patient enrolled in Madrid, Spain, on July 20, 2012. The Food and Drug Administration (FDA) approved the trial in the United States on September 10th. Additional international locations for the clinical trial are Belgium, France, Germany, Italy, Portugal, and the United Kingdom. In the United States, the trial will be conducted in California, Florida, Iowa, Louisiana, Massachusetts, Minnesota, New York, North Carolina, Pennsylvania, Tennessee, and Texas.
Known as NETTER-1, the study will evaluate the efficacy and safety of Lutathera® compared to high dose Octreotide LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors. According to Dr. Delpassand, “patients will be randomized to receive high doses (60 mg) Sandostatin® LAR versus 30 mg Sandostatin® LAR plus Lu-177 octreotate.” The primary objective of the trial is the assessment of Progression-Free Survival (PFS). Also being studied are safety, Objective Response Rate (ORR), Time to Tumor Progression (TTP), Overall Survival (OS), and Quality of Life (QoL).
Lutathera®, Lu-177 Octreotate, is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in differentiated neuroendocrine tumors. The Lu-177 is delivered directly into the tumor cell, acting like a Trojan horse. A Trojan horse in cancer therapy is the use of nanotechnology where cancer-fighting particles are targeted only for the cancer cells, leaving healthy cells alone. Lutathera® also releases a gamma ray, which exits the body and enables physicians to image and evaluate the progress of the treatment via a SPECT (Single Photon Emission Computer Tomography) camera.
Theragnostics is when a therapeutic drug is developed and is then approved to be used together with a diagnostic test. Advanced Accelerator Applications (AAA) in France is the company that is manufacturing Lutathera®. “Lutathera® is a true example of a theragnostic drug since its efficacy can be evaluated and monitored using imaging at every therapeutic injection, without additional costs.” (Read press release HERE)
Phase I/II results based on a clinical study of over 600 patients affected by different GEP-NETs, gastroenteropancreatic neuroendocrine tumors, performed at Erasmus Medical Centre in Rotterdam showed that Lutathera® extended patients’ lives by between 3.5 and 6 years in comparison to current treatments, including chemotherapy. Additionally, it was shown to significantly improve quality of life.
CLICK HERE to read more about the trial, including criteria for participants.
Interested individuals can contact Susan Cork, clinical coordinator of the project at Excel Diagnostics, for further information by email at email@example.com or at 713-341-3203.