TheranosticTrials.org

Clinical Trial · NCT02736500

Peptide Receptor Radionuclide Therapy With 177Lu-Dotatate Associated With Metronomic Capecitabine In Patients Affected By Aggressive Gastro-Etero-Pancreatic Neuroendocrine Tumors

Overview

The aim of this phase I-II study is to evaluate the efficacy and toxicity of PRRT with 177Lu-DOTATATE (Lu-PRRT) associated to metronomic chemotherapy with Capecitabine in patients affected by aggressive FDG-positive gastro-entero-pancreatic NET. Moreover to analyze the effects of the capecitabine metronomic schedule on the level of circulating angiogenetic factors.

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase

Phase 1/2

Contacts

Giovanni Paganelli, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02736500

Drug / Compound

DOTATATE

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

Eligibility

Inclusion

  • Before treatment clinical history data will be collected, physical examination will be performed and diagnostic and laboratory data will be examined.
  • Patients must be naive from previous radionuclide treatments with radiopeptides (e.g. 111Inpentetreotide, 90Y-DOTATOC) or other radiopharmaceuticals (e.s. 131I-MIBG, 131I).
  • Patients with documented disease will be admitted to therapeutic phase only if the diagnostic receptor imaging (OctreoScan) demonstrate a significant uptake in the tumor (grade 2 or 3, according to a preset scoring, where grade 1= equal to normal liver, grade2 = higher than normal liver, grade 3= higher than kidneys and spleen), that may allow delivering a low absorbed dose to normal organs and a high dose to the tumor.
  • Patients must not receive other treatments (e.g. chemo- or radiotherapy) from one month before to two months after the completion of 177Lu-DOTATATE cycles.
  • Histopathologic diagnosis of inoperable or metastatic gastro-entero-pancreatic neuroendocrine neoplasia.
  • Patients with documented disease will be admitted to therapeutic phase only if the 18FDG PET/CT is positive with a SUV \> 2.5 at least in one documented lesion.
  • Disease must be measurable by means of conventional imaging (CT or MRI).
  • Conserved hematological, liver and renal parameters: haemoglobin \>= 10 g/dL, absolute neutrophil count (ANC) \>= 1.5 x 109 /L, platelets \>= 100 x 109 /L, bilirubin ≤1.5 X UNL (upper normal limit), ALT \<2.5 X UNL (\< 5 X UNL in presence of liver metastases), creatinine \< 2 mg/dL.

Exclusion

  • ECOG score higher than 2.
  • Patients with psycho-physical conditions that are not suitable for entering this clinical study and fulfilling its requirements.
  • Expectancy of life shorter than 6 months.
  • Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory).
  • Assessed bone marrow invasion \> 25%.