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

Phase 2
14 Years
90 Years
Not Enrolling
Carcinoma, Neuroendocrine

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Trial Information

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

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.

Inclusion Criteria:

1. Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and
outside of the window of 10 days since the first day of the last menstrual period, a
negative pregnancy test is required.

2. Presence of somatostatin receptor positive tumour(s) (either histologically or
Octreoscan image proven), with at least 1 tumour site reliably evaluable by CT or MRI
of at least 1.5 cm (smallest dimension) with respect to RECIST criteria (the target

3. Presence of somatostatin receptors on (at least) the target lesion demonstrated by
uptake of OctreoScan® at least equal to liver uptake within 26 weeks of enrollment.

4. Life expectancy greater than 12 weeks from enrollment.

5. Serum creatinine ≤ 150 µmol/L, and a measured GFR using plasma clearance of ≥50
mL/min measured within 2 weeks of enrollment.

Exclusion Criteria:

1. Potential for surgery with curative intent. Local surgery for symptomatic relief
permitted as long as target lesion unaffected.

2. Surgery, radiation therapy, radioisotope therapy, change in Sandostatin LAR therapy
dosage, cytotoxic chemotherapy, embolization or other investigative therapy
(interferons, mTOR inhibitors) within 12 weeks of enrollment. Localized external beam
irradiation permitted as long as target lesion unaffected.

3. Known brain metastases unless these metastases have been treated and stabilized
(confirmed by CT) for ≥ 6 months prior to enrollment.

4. Uncontrolled diabetes mellitus defined as fasting glucose ≥ 3X the upper limit of
normal within 12 weeks of enrollment.

5. Another significant medical, psychiatric or surgical condition uncontrolled by
treatment, which may interfere with completion or conduct of the study (such as
urinary incontinence, co-existing malignancies).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumour response rate (modified RECIST criteria, CT/MRI or LU-177 scan) for the target lesion

Outcome Description:

Initial therapy includes 4 treatments over 7 months with evaluation of tumor response after each treatment. Further treatments are given, if approved by the investigator, once every 6 months with evalutation of tumor response after each additional treatment to evaluate continuation in the study for up to 5 years after enrollment .

Outcome Time Frame:

Initial therapy includes 4 treatments over 7 months

Safety Issue:


Principal Investigator

Alexander McEwan, MB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, Cross Cancer Institute


Canada: Health Canada

Study ID:




Start Date:

July 2013

Completion Date:

April 2021

Related Keywords:

  • Carcinoma, Neuroendocrine
  • 177lutetium-DOTA(O)Tyr3)octreotate
  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors