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


Condition: Carcinoma, Neuroendocrine

Intervention:

  • Other: Lu-DOTA-TATE radiopharmaceutical

Purpose: Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy has been shown to be a safe and effective palliative therapy. Lutetium-177 (Lu-DOTA-TATE) has been used at the Cross Cancer Institute to treat 91 patients with NETS since August, 2010. This study is being done because the investigators Lu-DOTA-TATE treatment is currently given under Health Canada's (HC) Special Access Programme (SAP), with each individual treatment requiring separate approval. HC has requested that the investigators conduct a clinical trial with Lu-DOTA-TATE, with the goal of receiving approval to use Lu-DOTA-TATE as a marketed treatment agent. There will be two groups of subjects: Group A (primary therapy) will have somatostatin receptor positive tumours; Group B (secondary therapy) will be those subjects who have currently been provided with Lu-DOTA-TATE under the SAP. All subjects will be treated in a therapeutic stage using 8-12 week dosing for 4 cycles followed by a maintenance stage using dosing at 22 to 26 week intervals for up to 8 cycles with a 22 to 26 week follow up after the last dose. Safety will be assessed by vital signs, blood work, renal function and adverse event collection.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01876771

Sponsor: AHS Cancer Control Alberta

Primary Outcome Measures:

  • Measure: Tumour response rate (modified RECIST criteria, CT/MRI or LU-177 scan) for the target lesion
  • Time Frame: 12, 24, 36 and 48 weeks, then if further treatment is approved at 12-16 months after start of treatment, every 22-30 weeks for up to 4 additional treatments for a total of up to 4 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Number of participants with adverse events as a measure of safety and tolerability
  • Time Frame: 12, 24, 36 and 48 weeks, then if further treatment is approved at 12-16 months after start of treatment, every 22-30 weeks for up to 4 additional treatments for a total of up to 4 years
  • Safety Issue:

Estimated Enrollment: 400

Study Start Date: April 2014

Phase: Phase 2

Eligibility:

  • Age: minimum 14 Years maximum 90 Years
  • Gender: All

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 lesion). 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. 6. Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 2 x 109/L; platelets ≥ 100 x 109/L measured within 2 weeks of enrolment. 7. Liver function tests (serum albumin, total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase) ≤ 3X the limit of normal measured within 2 weeks of enrolment. 8. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment. 9. Provide written informed consent prior to enrolment.

Exclusion Criteria:

  1. Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
  2. Surgery within 12 weeks of enrolment. Surgery for removal of superficial skin lesions, laser eye surgery or cataract surgery is permitted.
  3. Radioisotope therapy within 12 weeks of enrolment.
  4. Systemic therapy: mTOR inhibitors and tyrosine kinase inhibitors within 6 weeks of enrolment; chemotherapy and interferon within 12 weeks of enrolment.
  5. Change in long acting somatostatin analogues, dosage or dosage frequency within 12 weeks of enrolment.
  6. Localized external beam irradiation is permitted as long as the target lesion is not in the radiation field.
  7. Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 4 months prior to enrolment.
  8. Uncontrolled diabetes mellitus defined as fasting glucose ≥ 3X the upper limit of normal (or HbA1c > 10%, if results available) within 12 weeks of enrolment.
  9. 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).
  10. Pregnancy.
  11. Breastfeeding
  12. Prior radiation therapy to more than 25% of the bone marrow.

Contact:

  • Brent Schaitel, RN
  • 780-432-8873

Location:

  • Cross Cancer Institute
  • Edmonton Alberta T6G 1Z2 Canada

View trial on ClinicalTrials.gov


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