An Open-label, Phase II, Registry Study of Lutetium-177 [DOTA0, Tyr3] Octreotate (Lu-DOTA-TATE) Treatment in Subjects With Somatostatin Receptor Positive Tumours
A major group of somatostatin receptor positive tumours are those of neuroendocrine origin
(NETs), which comprise a spectrum of rare (<5%) neoplasms derived from primitive
neuroectodermal tissue. Because these neoplasms grow slowly and have symptoms that are
common in the general population, diagnosis is often delayed with advanced metastases at
presentation. Radiopharmaceuticals labelled with Lutetium-177 have been reported as
effective therapeutic agents in this population of patients, and used extensively by groups
in Europe, in particular Dr. Krenning's group at the University of Rotterdam. The peptide
DOTA0-tyr3-octreotate (DOTATATE) has been granted orphan drug status in the USA and in
Europe. Dr. Krenning et al have published data on over 300 patients, demonstrating the
safety and effectiveness of this treatment. They have shown stable disease, minimal, partial
and complete responses in 80% of patients treated with Lutetium-177 octreotate. They have
also shown comparable response rates in terms of improvements in symptoms and quality of
life. Coupled with a relatively benign safety profile the investigators believe this
treatment offers the realization of significant objective disease burden reduction and
improvements to the quality of life through symptomatic relief to NET subjects and intend
these benefits to be further demonstrated in this study. The Lu-DOTA-TATE used in this study
will be provided by the Edmonton Radiopharmaceutical Centre. The radiopharmaceutical is
manufactured under compliance with Health Canada requirements and each batch meets approved
quality control specifications.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumour response rate (modified RECIST criteria, CT/MRI or LU-177 scan) for the target lesion
Initial therapy includes 4 treatments over 7 months with evaluation of tumor response after each treatment. Further treatments are given, if approved by the investigator, once every 6 months with evalutation of tumor response after each additional treatment to evaluate continuation in the study for up to 5 years after enrollment .
Initial therapy includes 4 treatments over 7 months
No
Alexander McEwan, MB
Principal Investigator
Department of Oncology, Cross Cancer Institute
Canada: Health Canada
TX-LUT-001
NCT01876771
July 2013
April 2021
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