A Prospective Single-Arm, Multi-Centre, Study of the Efficacy and Safety of Lutetium-177 Octreotate (Lu-DOTATATE) Treatment With Individualized Dosimetry in Patients With 68Ga-DOTATATE Identified Somatostatin Receptor Positive Neuroendocrine Tumors

University Health Network, Toronto4 sites in 1 country195 target enrollmentJuly 15, 2016

ConditionsNeuroendocrine Tumors

InterventionsLutetium-177 Octreotate

Overview

Phase: Not Applicable
Intervention: Lutetium-177 Octreotate
Conditions: Neuroendocrine Tumors
Sponsor: University Health Network, Toronto
Enrollment: 195
Locations: 4
Primary Endpoint: The proportion of patients progression-free using RECIST 1.1 criteria
Status: Active, not recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.

Registry

clinicaltrials.gov

Start Date

July 15, 2016

End Date

June 1, 2026

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Biopsy-proven neuroendocrine tumor
•ECOG performance status ≤ 2
•Ki-67 index ≤ 30%
•Evidence of progressive disease demonstrated by imaging within six months prior to study enrollment as defined by RECIST v1.
•Tumor board discussion of cases to confirm suitability for participation in the clinical trial is required. Review should include but not limited to imaging review, pathology (including Ki 67) and treatment options.
•Patients with objective evidence (imaging, or biochemical) that is insufficient to be classified by RECIST 1.1 criteria can be eligible if after provincial multidisciplinary tumor board discussion a consensus for progression eligibility is reached.
•The tumor board would consider exemptions if the magnitude of change is adequate by other definitions (e.g. using structural and contrast patterns and biochemical changes).
•Where clinically indicated, formal consultation on pathology, diagnostic imaging to facilitate criteria assessment (including 68Ga PET performed as part of the diagnostic procedure) is strongly recommended.
•Adequate lab parameters within 2 weeks prior to enrollment:
•Serum creatinine ≤ 150 μmol/L

Exclusion Criteria

•Life expectancy \<12 weeks
•An option for curative surgical or medical therapy or local liver embolization is feasible
•Candidate for curative and/or debulking surgical resections
•Systemic, biologic, other radioisotope, embolization therapies within ≤4 weeks prior to the first dose of 177Lu.
•Prior radiotherapy to target lesion(s) within ≤12 weeks prior to study enrollment \[radiotherapy to non-target lesions permitted\].
•Prior therapy with any systemic radionuclide therapy.
•Radiotherapy to more than 25% of the bone marrow.
•Known brain metastases (unless metastases have been treated and are stable for ≥ 6 months).
•Uncontrolled diabetes mellitus
•Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary incontinence).

Arms & Interventions

Lutetium-177 Octreotate

Lutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks

Intervention: Lutetium-177 Octreotate

Outcomes

Primary Outcomes

The proportion of patients progression-free using RECIST 1.1 criteria

Time Frame: Up to 12 months

Secondary Outcomes

The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)(Up to 5 years)
The overall response rate as determined by structural imaging using RECIST criteria.(Up to 5 years)
The biochemical response rate (as defined by biochemical responses: serum chromogranin A and 24 hr urinary 5HIAA).(Up to 5 years)
The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03(Up to 5 years)
Overall survival(Up to 5 years)