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

NCT02489604 | Terminated Phase 2

• 1 other identifier: IRST100.11
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Neuroendocrine Tumors

Keywords

neuroendocrine tumors

Outcome Measures

Primary Outcomes (2)

• Disease control rate (DCR)

  the complete response rate plus the partial response rate plus the rate of patients with stable disease for at least 12 months from therapy start on patient population randomly assigned to two different scheme of therapy

  up to 7 years

• Acute toxicity evaluated according to version 4.0 CTCAE

  The co-primary objective is the acute toxicity evaluated according to version 4.0 CTCAE

  The evaluation of the acute toxicity starts from the 1st treatment until 30 days after the last treatment cycle, up to 60 wks for each patient

Secondary Outcomes (3)

• Progression free survival

  up to 7 years

• Overall survival

  up to 7 years

• Late toxicity evaluated according to version 4.0 CTCAE

  up to 7 years

Study Arms (2)

177Lu-DOTATATE 25.9 GBq activity

EXPERIMENTAL

177Lu-DOTATATE 25.9 GBq activity. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)

Drug: 177Lu-DOTATATE 25.9 GBq activity

177Lu-DOTATATE 18.5 GBq activity

EXPERIMENTAL

177Lu-DOTATATE 18.5 GBq activity. Total activity of 18.5 GBq 100 mCi for 5 cycles, every 6 ± 2 weeks (500 mCi)

Drug: 177Lu-DOTATATE 18.5 GBq activity

Interventions

177Lu-DOTATATE 25.9 GBq activity DRUG

177Lu-DOTATATE will be administered in a 30 minutes infusion. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)

Also known as: 177Lu-DOTATATE

177Lu-DOTATATE 25.9 GBq activity

177Lu-DOTATATE 18.5 GBq activity DRUG

177Lu-DOTATATE will be administered in a 30 minutes infusion Total activity of 18.5 GBq 100 mCi for 5 cycles , every 6 ± 2 weeks (500 mCi)

Also known as: 177Lu-DOTATATE

177Lu-DOTATATE 18.5 GBq activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Advanced GEP-NET are eligible; patients must have progressive disease based on RECIST 1.1. criteria
• Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour
• FDG PET negative (SUV less than 2.5)
• Concomitant somatostatin analogs assumption is allowed
• Life expectancy greater than 6 months.
• ECOG performance status \<2
• 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.
• 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.
• Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

• Ki 67 index \> 20 %
• FDG PET positive at least in one documented lesion with a SUV more than 2.5
• Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy).
• 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.
• 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)
• Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
• 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.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (1)

Irst Irccs

Meldola, FC, 47014, Italy

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Maddalena Sansovini, MD

  IRST IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: July 3, 2015
• Study Start: December 1, 2013
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

IT (1)