An Open Label Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours

Inclusion Criteria:

Group A: Primary therapy subjects will be included in the study if they meet all of the following general 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 lesion).
3. Presence of somatostatin receptors on (at least) the target lesion demonstrated by uptake of OctreoScan® at least equal to liver uptake within 12 weeks of enrollment.
4. Life expectancy greater than 26 weeks from enrollment.
5. Serum creatinine ≤ 130 μmol/L, and a measured glomerular filtration rate (GFR) using plasma clearance of ≥50 mL/min measured within 2 weeks of enrollment.
6. Haemoglobin concentration ≥ 90 g/L; white blood cell count (WBC) ≥ 3 x 109/L; platelets ≥ 100 x 109/L measured within 2 weeks of enrollment.
7. Liver function tests (serum albumin, total bilirubin, alanine amniotransferase (ALT),aspartate aminotransferase (AST) and alkaline phosphatase) ≤ 3 X the limit of normal.
8. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrollment.
9. Provide written informed consent prior to enrollment.
10. Ki 67 < 20%, unless patients has been treated with chemotherapy and lesions are stable (Ki 67 < 30%)

Group B: Secondary therapy subjects will be included in the study if they meet all of the following general 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. Have received Lu-DOTA-TATE treatment at the London Health Sciences Centre under the Special Access Programed or other radionuclide therapy for neuroendocrine tumor.
3. Provide written informed consent prior to enrollment.

Exclusion Criteria:

Group A: Primary therapy subjects will be excluded from the study if they meet any of the following 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, mammalian target of rapamycin (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 or stable (confirmed by CT) for ≥ 6 months prior to enrollment
4. Uncontrolled diabetes mellitus defined as fasting glucose ≥ 3 X 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).
6. Pregnancy.
7. Breast feeding.
8. Prior radiation therapy to more than 25% of the bone marrow.

Group B: Secondary therapy subjects will be excluded from the study if they meet any of the following criteria:

1. 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).
2. Pregnancy.
3. Breast feeding.