TheranosticTrials.org

Clinical Trial · NCT02125474

Efficacy of 177-Lu-DOTA 0, Tyr 3 Octreotate

Overview

Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing number of new cases reported in the annual statistics of the Instituto Nacional de Cancerología (INC). The majority are advanced-stage presentations with limited chances of a complete surgical resection of the primary tumor, a clinical scenario where medical treatment options are also limited. In view of the characteristically defined expression of peptide receptors in WDNETs, radioactive molecular probes to target specific cellular receptors have been designed using radioisotopes with short range of penetration in tissues. We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-\[DOTA 0, Tyr 3\] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET. Selected patients matching inclusion criteria will be enrolled at the INC's Section of Endocrinology. Tumor response, treatment safety (side effects) and survival will be appraised. Data from clinical, biochemical and imaging follow-up will be periodically registered during treatment and until two years after the last infusion of 177Lu- DOTATATE. This phase II trial is justified because despite the fact that many preclinical and clinical studies have showed the potential usefulness of this novel palliative approach to treat patients with advanced-stage WDNETs there is a paucity of vigorous results to establish its efficacy as first-line treatment.

Sponsor

Unknown Organization

Phase

N/A

Contacts

Carmen A De los Reyes, Md (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02125474

Drug / Compound

DOTATATE

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

Eligibility

Inclusion

  • Platelets (Plaq) \> 80 x 103/µl
  • Creatinine clearance \> 40 ml/min and serum creatinine \< 1.5 mg/dl and/or isotopic glomerular filtration rate \> 50 ml/min.
  • Life expectancy \> 3 months.
  • Total Bilirrubin (BT) ≤ 3 times the upper limit of normal range. Serum albumin \> 3 g/dl and normal prothrombin time.
  • Hemoglobin (Hb) \> 8.8 g/dl
  • Karnofsky functional score \> 60.
  • Non-lactating woman with negative pregnancy blood test.
  • At least one measurable CT tumor lesion.
  • Test results should predate treatment by at least: blood test results ≤ 4 weeks, liver blood tests \< 1 month, renal function tests \< 1 week, CT ≤ 4 months and 99mTc-HYNIC-TOC scintigraphy \< 6 months.
  • Multiple inoperable metastatic sites.
  • Leucocytes (Leu) \> 2 x 103/µl
  • Somatostatin receptor-positive tumors with at least one site of abnormal focal uptake \> liver physiologic uptake (3+) observed in a 99mTc-HYNIC-TOC scintigraphy practiced less than 6 months before treatment with 177Lu- DOTATATE.
  • Patient voluntarily willing to participate in the trial.
  • Histopathologic diagnosis confirmed at the Instituto Nacional de Cancerología.
  • Patients with inoperable gastroenteropancreatic neuroendocrine tumors.

Exclusion

  • Patients previously treated with radionuclide therapy.
  • Patients treated with chemo- o radiotherapy within the past 6 months.
  • Patients unable to comply with clinical follow-up in both Nuclear Medicine and Endocrinology units.