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

NCT02236910

Description:

Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as being effective in controlling symptoms and increase quality of life; induce stable disease and extend progression free survival; induce a (good) partial remission and induce a complete remission in patients with a somatostatin receptor positive tumour. The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE, and the quality of life of the patients treated with Lu-DOTA-TATE.

Related Conditions:
  • Neuroendocrine Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open Label Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours
  • Official Title: An Open Label Phase II, Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients With Somatostatin Receptor Positive Tumours

Clinical Trial IDs

  • ORG STUDY ID: TX-LUT-001-London
  • SECONDARY ID: Lu-DOTA-TATE
  • NCT ID: NCT02236910

Conditions

  • Neuroendocrine Carcinoma

Purpose

Lu-DOTA-TATE (Lutetium-177 octreotate) is a radiopharmaceutical that has been reported as being effective in controlling symptoms and increase quality of life; induce stable disease and extend progression free survival; induce a (good) partial remission and induce a complete remission in patients with a somatostatin receptor positive tumour. The purpose of this study is to assess the efficacy of Lu-DOTA-TATE by measuring progression free survival and overall survival. This study will also asses the safety of Lu-DOTA-TATE, and the quality of life of the patients treated with Lu-DOTA-TATE.

Detailed Description

      Neuroendocrine (NET) tumours have secretory and metabolic pathways not typically found in
      other cancers that can be utilized for molecular imaging and therapeutic targeting. The most
      important is somatostatin. Somatostatin receptors are useful tools in the diagnosis and
      treatment of NET tumours because the somatostatin analogue octreotate can be radiolabeled
      with lutetium-177 for imaging and therapy.

      In selected populations of patients, radioisotope therapy in expert hands has been shown to
      be a safe and effective palliative therapy with stable disease, progression free survival
      benefit, symptom control and improvements in quality of life. Lutetium-177 (DOTA0, Tyr3)
      octreotate has been used in a significant number of clinical studies shown to be safe and
      effective as a therapeutic agent in patients with NET tumours. The investigators intend to
      further confirm these benefits with lutetium-177 octreotate, which could form the basis for a
      national registry study leading to registration of this therapeutic intervention.
    

Trial Arms

NameTypeDescriptionInterventions
Primary Therapy with Lu-DOTA-TATEExperimentalLu-DOTA-TATE (Lutetium-177 Octreotate) will be administered by intravenous infusion to participants who have not been previously treated with Lu-DOTA-TATE
    Secondary Therapy with Lu-DOTA-TATEExperimentalPatients who have received previous treatment with Lu-DOTA-TATE (Lutetium-177 Octreotate) under the special access program are eligible to be treated in this study. Patients will receive Lu-DOTA-TATE by intravenous infusion.

      Eligibility Criteria

              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.
            
      Maximum Eligible Age:90 Years
      Minimum Eligible Age:14 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Tumour response measured by RECIST criteria
      Time Frame:7 years (end of study)
      Safety Issue:
      Description:Target lesions will be assigned after treatment 1 base done either the Lu-177 scan, or the CT/MRI scan within 2 weeks prior to treatment 1. Tumour response will be measured using response evaluation criteria in solid tumours (RECIST).

      Secondary Outcome Measures

      Measure:Progression Free Survival
      Time Frame:7 years (end of study)
      Safety Issue:
      Description:Progression free survival will be measured from the date of enrollment to the date the target lesion progresses as per RECIST criteria, or death sue to any cause.
      Measure:Quality of Life
      Time Frame:7 years (end of study)
      Safety Issue:
      Description:Quality of life changes due to treatment with Lu-DOTA-TATE, measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire(QLQ) EORTC QLQ-C30.

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Lawson Health Research Institute

      Trial Keywords

      • somatostatin receptor positive tumour

      Last Updated

      August 24, 2017