TheranosticTrials.org

Clinical Trial · NCT02743741

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

Overview

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.

Sponsor

University Health Network, Toronto

Phase

N/A

ClinicalTrials.gov

NCT02743741

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • ALT ≤ 5 x ULN
  • Adequate lab parameters within 2 weeks prior to enrollment:
  • Adequate liver function tests within 2 weeks prior to enrollment:
  • ECOG performance status ≤ 2
  • 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.
  • Calculated CrCl or measured GFR ≥ 30 mL/min (measured GFR may be done within 4 weeks prior to enrollment)
  • total bilirubin ≤ 5 x ULN
  • Evidence of progressive disease demonstrated by imaging within six months prior to study enrollment as defined by RECIST v1.1.
  • 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.
  • Ki-67 index ≤ 30%
  • 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.
  • alkaline phosphatase ≤ 5 x ULN
  • Patients with extensive bone metastases (e.g. \>25% of bone marrow involvement are eligible but requires careful monitoring of hematological reserve
  • WBC ≥ 2 x 109/L
  • AST ≤ 5 x ULN
  • Subject's willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Haemoglobin ≥ 90 g/L
  • Platelets ≥ 100 x 109/L
  • Serum creatinine ≤ 150 μmol/L
  • Biopsy-proven neuroendocrine tumor
  • 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).

Exclusion

  • Candidate for curative and/or debulking surgical resections
  • Known brain metastases (unless metastases have been treated and are stable for ≥ 6 months).
  • 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.
  • Radiotherapy to more than 25% of the bone marrow.
  • Co-morbidities that may interfere with delivery of 177Lu (e.g. urinary incontinence).
  • An option for curative surgical or medical therapy or local liver embolization is feasible
  • Prior radiotherapy to target lesion(s) within ≤12 weeks prior to study enrollment \[radiotherapy to non-target lesions permitted\].
  • Life expectancy \<12 weeks
  • Systemic, biologic, other radioisotope, embolization therapies within ≤4 weeks prior to the first dose of 177Lu.
  • Prior therapy with any systemic radionuclide therapy.
  • Second cancer(s) with clinical or biochemical progression within the last 3 years.
  • 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
  • Uncontrolled diabetes mellitus