Clinical Trial · NCT02489604

Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors

Overview

This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq).

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase

Phase 2

Contacts

Maddalena Sansovini, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02489604

Eligibility

Inclusion

Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
Advanced GEP-NET are eligible; patients must have progressive disease based on RECIST 1.1. criteria
ECOG performance status \<2
Concomitant somatostatin analogs assumption is allowed
FDG PET negative (SUV less than 2.5)
Adequate haematological, liver and renal function: haemoglobin \>= 9 g/dL, absolute neutrophil count (ANC) \>= 1.5 x 109 /L, platelets \>= 100 x 109 /L, bilirubin ≤1.5 X upper normal limit (UNL) , Alanine transaminase (ALT) \<2.5 X UNL (\< 5 X UNL in presence of liver metastases), creatinine \< 2 mg/dL.
Life expectancy greater than 6 months.
If female of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment.
Patients must have histologically or cytologically confirmation of GEP -NETand Ki 67 index \<= 20%.
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.criteria)

Exclusion

Ki 67 index \> 20 %
Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
History of allergic reactions attributed to compounds of similar chemical or biologic composition
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade \<= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)
Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy).
FDG PET positive at least in one documented lesion with a SUV more than 2.5
Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow.