TheranosticTrials.org

Clinical Trial · NCT03422029

Efficacy and Safety of 177Lu-Dotatate PRRT in Metastatic GEP-NEN Patients

Overview

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Dotatate in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of GEP-NEN

Sponsor

Peking University First Hospital

Phase

Phase 2

ClinicalTrials.gov

NCT03422029

Drug / Compound

Dotatate

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

Eligibility

Inclusion

  • unresectable metastatic tumors confirmed by radiological imaging;
  • Predicted survival \>=3 months;
  • Screening laboratory values must meet the following criteria (within past 7 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10\^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN;
  • Sexually active males or females willing to practice contraception during the study until 30 days after end of study.
  • At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan \>=20mm, spiral CT scan \>=10mm, no prior radiation to measurable lesions);
  • KPS ≥ 70;
  • pathologically confirmed well-differentiated neuroendocrine tumors;
  • Somatostatin receptor positive (SSTR+) disease;
  • Radiological disease progression within 12 months, defined as progressive disease per RECIST 1.1. criteria
  • No more than 2 prior antitumor drugs, including somatostatin analogs, targeted drugs and chemotherapy, with the last dose over 4 weeks;

Exclusion

  • Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to \> 2 weeks of study enrollment)；
  • Hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative;
  • Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
  • Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.
  • Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
  • Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
  • Meningeal carcinomatosis;
  • Concurrent severe infection；
  • Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
  • Received surgery within past 4 weeks, or have not recovered from surgery;
  • Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
  • Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；