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

Prior treatment

• Group A: Primary therapy subjects will be excluded from the study if they meet any of the following criteria:
• Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
• 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.
• Known brain metastases unless these metastases have been treated or stable (confirmed by CT) for ≥ 6 months prior to enrollment
• 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:

Other illness

• 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).
• 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).

Lab values

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

Other

• Pregnancy.
• Breast feeding.
• Pregnancy.
• Breast feeding.

• Group A: Primary therapy subjects will be included in the study if they meet all of the following general criteria:
• 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.
• 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).
• 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.
• Life expectancy greater than 26 weeks from enrollment.
• 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.
• 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.
• Liver function tests (serum albumin, total bilirubin, alanine amniotransferase (ALT),aspartate aminotransferase (AST) and alkaline phosphatase) ≤ 3 X the limit of normal.
• Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrollment.
• Provide written informed consent prior to enrollment.
• 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:
• 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.
• Have received Lu-DOTA-TATE treatment at the London Health Sciences Centre under the Special Access Programed or other radionuclide therapy for neuroendocrine tumor.
• Provide written informed consent prior to enrollment.