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

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Collaborator: Istituto Europeo di Oncologia IEO MILANO
• Treatments: Capecitabine; Lutetium Lu 177 dotatate; Octreotide

Criteria

Inclusion Criteria:

• Histopathologic diagnosis of inoperable or metastatic gastro-entero-pancreatic neuroendocrine neoplasia.

• 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.

• Age more than 18 years.

• 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 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).

• Before treatment clinical history data will be collected, physical examination will be performed and diagnostic and laboratory data will be examined.

• 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.

• Patients must be naive from previous radionuclide treatments with radiopeptides (e.g. 111Inpentetreotide, 90Y-DOTATOC) or other radiopharmaceuticals (e.s. 131I-MIBG, 131I).

Exclusion Criteria:

• Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory).

• Assessed bone marrow invasion > 25%.

• Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers).

• ECOG score higher than 2.

• Expectancy of life shorter than 6 months.

• Patients with psycho-physical conditions that are not suitable for entering this clinical study and fulfilling its requirements.