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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 August 2023
• Main ID: NCT02743741
• Date of registration: 13/04/2016
• Prospective Registration: Yes
• Primary sponsor: University Health Network, Toronto
• Public title: Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
• Scientific title: 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
• Date of first enrolment: July 15, 2016
• Target sample size: 195
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02743741
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Please note that only Ontario residents will be eligible for participation in this trial.

Inclusion Criteria:

1. Biopsy-proven neuroendocrine tumor

2. ECOG performance status = 2

3. Ki-67 index = 30%

4. 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.

5. 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

6. Adequate liver function tests within 2 weeks prior to enrollment:

- total bilirubin = 5 x ULN

- ALT = 5 x ULN

- AST = 5 x ULN

- alkaline phosphatase = 5 x ULN

7. Signed informed consent

8. Patients with extensive bone metastases (e.g. >25% of bone marrow involvement are
eligible but requires careful monitoring of hematological reserve

9. Subject's willingness and ability to comply with scheduled visits, treatment plans,
laboratory tests, and other study procedures.

10. Age = 18 years.

Exclusion Criteria:

1. Life expectancy <12 weeks

2. An option for curative surgical or medical therapy or local liver embolization is
feasible

3. Candidate for curative and/or debulking surgical resections

4. Systemic, biologic, other radioisotope, embolization therapies within =4 weeks prior
to the first dose of 177Lu.

5. Prior radiotherapy to target lesion(s) within =12 weeks prior to study enrollment
[radiotherapy to non-target lesions permitted].

6. Prior therapy with any systemic radionuclide therapy.

7. Radiotherapy to more than 25% of the bone marrow.

8. Known brain metastases (unless metastases have been treated and are stable for = 6
months).

9. Uncontrolled diabetes mellitus

10. Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary incontinence).

11. Second cancer(s) with clinical or biochemical progression within the last 3 years.

12. 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

13. 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Neuroendocrine Tumors

Intervention(s)

Drug: Lutetium-177 Octreotate

Primary Outcome(s)

The proportion of patients progression-free using RECIST 1.1 criteria [Time Frame: Up to 12 months]

Secondary Outcome(s)

Overall survival [Time Frame: Up to 5 years]

The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03 [Time Frame: Up to 5 years]

The overall response rate as determined by structural imaging using RECIST criteria. [Time Frame: Up to 5 years]

The biochemical response rate (as defined by biochemical responses: serum chromogranin A and 24 hr urinary 5HIAA). [Time Frame: Up to 5 years]

The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu) [Time Frame: Up to 5 years]

Secondary ID(s)

OZM-067

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Canadian Molecular Imaging Probe Consortium

Ozmosis Research Inc.

Cancer Care Ontario