A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours

Official Title

An Open-label, Phase II, Registry Study of Lutetium-177 [DOTA0, Tyr3] Octreotate (Lu-DOTA-TATE) Treatment in Subjects With Somatostatin Receptor Positive Tumours


Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy has been shown to be a safe and effective palliative therapy. Lutetium-177 (Lu-DOTA-TATE) has been used at the Cross Cancer Institute to treat 91 patients with NETS since August, 2010. This study is being done because the investigators Lu-DOTA-TATE treatment is currently given under Health Canada's (HC) Special Access Programme (SAP), with each individual treatment requiring separate approval. HC has requested that the investigators conduct a clinical trial with Lu-DOTA-TATE, with the goal of receiving approval to use Lu-DOTA-TATE as a marketed treatment agent. There will be two groups of subjects: Group A (primary therapy) will have somatostatin receptor positive tumours; Group B (secondary therapy) will be those subjects who have currently been provided with Lu-DOTA-TATE under the SAP. All subjects will be treated in a therapeutic stage using 8-12 week dosing for 4 cycles followed by a maintenance stage using dosing at 22 to 26 week intervals for up to 8 cycles with a 22 to 26 week follow up after the last dose. Safety will be assessed by vital signs, blood work, renal function and adverse event collection.

Trial Description

Primary Outcome:

  • Tumour response rate (modified RECIST criteria, CT/MRI or LU-177 scan) for the target lesion
Secondary Outcome:
  • Number of participants with adverse events as a measure of safety and tolerability
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.

View this trial on ClinicalTrials.gov

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