Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors

NCT02743741 | Active Not Recruiting DMC

• 1 other identifier: OZM-067
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 4

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.

Conditions

Neuroendocrine Tumors

Keywords

Somatostatin Receptor Positive Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• The proportion of patients progression-free using RECIST 1.1 criteria

  Up to 12 months

Secondary Outcomes (5)

• 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

• The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)

  Up to 5 years

Study Arms (1)

Lutetium-177 Octreotate

EXPERIMENTAL

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

Drug: Lutetium-177 Octreotate

Interventions

Lutetium-177 Octreotate DRUG

Radiopharmaceutical

Also known as: Lu-DOTATATE, [Lu-177]-DOTATATE

Lutetium-177 Octreotate

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 v1.1.
• 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
• Calculated CrCl or measured GFR ≥ 30 mL/min (measured GFR may be done within 4 weeks prior to enrollment)
• Haemoglobin ≥ 90 g/L
• WBC ≥ 2 x 109/L
• Platelets ≥ 100 x 109/L
• Adequate liver function tests within 2 weeks prior to enrollment:

You may not qualify if:

• 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).
• Second cancer(s) with clinical or biochemical progression within the last 3 years.
• Pregnancy or breast feeding. Female subjects must be surgically sterile or postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrolment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
• Other condition, illness, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation, 68Ga or 177Lu administration, or may interfere with the interpretation of study results and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ozmosis Research Inc.: collaborator
• Cancer Care Ontario: collaborator
• Canadian Molecular Imaging Probe Consortium: collaborator

Study Sites (4)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Sunnybrook Odette Cancer Center

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 19, 2016
• Study Start: July 15, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CA (4)