TheranosticTrials.org

Clinical Trial · NCT04915144

177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs

Overview

This study is to assess if personalized peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATOC results in fewer adverse events than standard PRRT. Subjects will be randomized to either receive personalized or standard PRRT. Personalized PRRT will be determined based on dosimetry calculations after the first cycle. In addition comparisons, will be made with progression-free survival, serial CT imaging, ctDNA, and quality of life questionnaires. Subjects will be followed for 5 years or until they have progression and are switched to another systemic treatment (not including treatment with somatostatin analogues).

Sponsor

British Columbia Cancer Agency

Phase

Phase 2

Contacts

Francois Benard, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04915144

Drug / Compound

DOTATOC

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

Eligibility

Inclusion

  • GFR ≥ 40 ml/min (using plasma clearance values)
  • Adequate laboratory parameters within two weeks of enrollment
  • Gastroenteropancreatic tumors (e.g. carcinoids, gastrinoma, insulinoma, glucagonoma, VIPoma, etc.), functioning and non-functioning
  • WBC ≥ 2 x 109/L
  • Total bilirubin ≤ 3 x upper limit of normal (ULN)
  • Marrow
  • ALT ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis
  • Biopsy-proven, well-differentiated grade 1 - 3 NET
  • Serum creatinine ≤ 150 µmol/L
  • Progressive disease demonstrated by RECIST 1.1 criteria within the 6 months preceding the study.
  • Hemoglobin ≥ 80 g/L
  • Kidneys
  • If response to other treatments is considered adequate according to other criteria, the Tumour Review Board may consider excluding the patient from participation in the study.
  • Positive PET SSR imaging (Krenning score 2 or higher) in previous 6 months (68Ga-DOTATOC, 68Ga-DOTATATE, 18F-AmBF3-TATE). If PET SSR imaging is not available 111In-penetreotide scintigraphy (Octreotide scan) is acceptable.
  • Liver
  • Alkaline phosphatase ≤ 3 x ULN or ≤ 5 x ULN if liver metastasis
  • Easter Cooperative Oncology Group (ECOG) ≤ 2
  • Ki67 ≤ 55%
  • Subject's ability to comply with scheduled visits, treatment plans, laboratory tests, imaging tests, and other procedures required as detailed in the protocol.
  • Tumour Review Board confirmation of suitability to proceed to PRRT treatment and enrollment in this trial.
  • Platelets ≥ 75 x 109/L
  • Patients with other evidence of progressive disease that is not demonstrated on CT (like rising biomarkers) may be included, at the discretion of the Tumour Review Board.
  • Pulmonary NET, functioning and non-functioning

Exclusion

  • Radiotherapy to target lesions ≤ 12 weeks ago or to more than 25% of bone marrow.
  • Breastfeeding (if patients elect to discontinue breast feeding, they can participate in the trial).
  • Men: must be surgically sterile or use adequate contraception for the duration of the therapy.
  • Life expectancy is less than 12 weeks.
  • Curative medical or surgical treatment, local liver embolization, or debulking are appropriate options.
  • Co-morbidities that could, in the opinion of the PI, interfere with safe delivery of PRRT (like urinary incontinence, psychiatric illness), uncontrolled congestive heart failure (NYHA II, III, IV)
  • Known brain metastases (unless treated and stable for more than 3 months).
  • Women: pregnancy test done before enrollment before each treatment cycle. And subject must use adequate contraception for the duration of therapy, be surgically sterile, or post-menopausal.
  • PRRT at any time prior to randomization in this study.
  • Systemic therapy (chemotherapy) within 4 weeks of PRRT and other locoregional therapies (radioisotope, embolization) within 12 weeks prior to enrollment. Ongoing use of somatostatin analogs for control of symptoms is allowed.
  • Women and men of childbearing potential Procreation