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.
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