Clinical Trials /

Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors

NCT02743741

Description:

This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.

Related Conditions:
  • Neuroendocrine Tumor
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
  • Official Title: A Prospective Single-Arm, Multi-Centre, Study of the Efficacy and Safety of Lutetium-177 Octreotate (Lu-DOTATATE) Treatment With Individualized Dosimetry in Patients With 68Ga-DOTATATE Identified Somatostatin Receptor Positive Neuroendocrine Tumors

Clinical Trial IDs

  • ORG STUDY ID: OZM-067
  • NCT ID: NCT02743741

Conditions

  • Neuroendocrine Tumors

Interventions

DrugSynonymsArms
Lutetium-177 OctreotateLu-DOTATATE, [Lu-177]-DOTATATELutetium-177 Octreotate

Purpose

This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.

Trial Arms

NameTypeDescriptionInterventions
Lutetium-177 OctreotateExperimentalLutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks
  • Lutetium-177 Octreotate

Eligibility Criteria

        Please note that only Ontario residents will be eligible for participation in this trial.

        Inclusion Criteria:

          1. Biopsy-proven neuroendocrine tumor

          2. ECOG performance status ≤ 2

          3. Ki-67 index ≤ 30%

          4. Evidence of progressive disease demonstrated by imaging within six months prior to
             study enrollment as defined by RECIST v1.1.

               -  Tumor board discussion of cases to confirm suitability for participation in the
                  clinical trial is required. Review should include but not limited to imaging
                  review, pathology (including Ki 67) and treatment options.

               -  Patients with objective evidence (imaging, or biochemical) that is insufficient
                  to be classified by RECIST 1.1 criteria can be eligible if after provincial
                  multidisciplinary tumor board discussion a consensus for progression eligibility
                  is reached.

               -  The tumor board would consider exemptions if the magnitude of change is adequate
                  by other definitions (e.g. using structural and contrast patterns and biochemical
                  changes).

               -  Where clinically indicated, formal consultation on pathology, diagnostic imaging
                  to facilitate criteria assessment (including 68Ga PET performed as part of the
                  diagnostic procedure) is strongly recommended.

          5. Adequate lab parameters within 2 weeks prior to enrollment:

               -  Serum creatinine ≤ 150 μmol/L

               -  Calculated CrCl or measured GFR ≥ 30 mL/min (measured GFR may be done within 4
                  weeks prior to enrollment)

               -  Haemoglobin ≥ 90 g/L

               -  WBC ≥ 2 x 109/L

               -  Platelets ≥ 100 x 109/L

          6. Adequate liver function tests within 2 weeks prior to enrollment:

               -  total bilirubin ≤ 5 x ULN

               -  ALT ≤ 5 x ULN

               -  AST ≤ 5 x ULN

               -  alkaline phosphatase ≤ 5 x ULN

          7. Signed informed consent

          8. Patients with extensive bone metastases (e.g. >25% of bone marrow involvement are
             eligible but requires careful monitoring of hematological reserve

          9. Subject's willingness and ability to comply with scheduled visits, treatment plans,
             laboratory tests, and other study procedures.

         10. Age ≥ 18 years.

        Exclusion Criteria:

          1. Life expectancy <12 weeks

          2. An option for curative surgical or medical therapy or local liver embolization is
             feasible

          3. Candidate for curative and/or debulking surgical resections

          4. Systemic, biologic, other radioisotope, embolization therapies within ≤4 weeks prior
             to the first dose of 177Lu.

          5. Prior radiotherapy to target lesion(s) within ≤12 weeks prior to study enrollment
             [radiotherapy to non-target lesions permitted].

          6. Prior therapy with any systemic radionuclide therapy.

          7. Radiotherapy to more than 25% of the bone marrow.

          8. Known brain metastases (unless metastases have been treated and are stable for ≥ 6
             months).

          9. Uncontrolled diabetes mellitus

         10. Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary incontinence).

         11. Second cancer(s) with clinical or biochemical progression within the last 3 years.

         12. Pregnancy or breast feeding. Female subjects must be surgically sterile or
             postmenopausal, or must agree to use effective contraception during the period of
             therapy. All female subjects with reproductive potential must have a negative
             pregnancy test (serum) prior to enrolment. Male subjects must be surgically sterile or
             must agree to use effective contraception during the period of therapy. The definition
             of effective contraception will be based on the judgment of the principal investigator
             or a designated associate

         13. Other condition, illness, psychiatric condition, or laboratory abnormality that may
             increase the risk associated with study participation, 68Ga or 177Lu administration,
             or may interfere with the interpretation of study results and in the judgment of the
             investigator would make the patient inappropriate for entry into this study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The proportion of patients progression-free using RECIST 1.1 criteria
Time Frame:Up to 12 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:The overall response rate as determined by structural imaging using RECIST criteria.
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:The biochemical response rate (as defined by biochemical responses: serum chromogranin A and 24 hr urinary 5HIAA).
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Overall survival
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)
Time Frame:Up to 5 years
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University Health Network, Toronto

Trial Keywords

  • Somatostatin Receptor Positive Neuroendocrine Tumors

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