Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver

Running, not enrolling · Early Phase 1

Conditions studied: Neuroendocrine Tumors, Liver-Dominant Metastatic Pancreatic Neuroendocrine Tumors

In brief

This study will look at whether it is practical and safe to give Lutathera directly into an artery of the liver (hepatic intraarterial infusion). The researchers will compare the effects of hepatic intraarterial infusion in the liver with the effects of the standard approach (intravenous infusion in the arm). The researchers will also determine whether Lutathera is effective against participants' cancer.

Key facts

Study ID

NCT04544098

Run by

Memorial Sloan Kettering Cancer Center

People needed

10

Starts

2020-09-02

Expected to finish

2027-09-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects affected by histologically proven, somatostatin-receptor positive, progressive, nonresectable, liver-dominant metastatic GEP, bronchial or unknown primary tumors, G1, G2 and G3, according to the new WHO classification of 2017.
• Ability to understand and willingness to sign a written informed consent document
• Aged 18 years or older
• Histologically proven or cytologically confirmed, non-resectable,GEP, bronchial or unknown primary NETs with liver-dominant disease with or without prior treatment with embolization
• Measurable disease as defined by RECIST 1.1 with at least one dimension ≥ 1.0 cm
• GEP or unknown primary NET of grade 1, 2 and 3 according to WHO 2017, typical or atypical lung carcinoid according to the Travis classification of 2004
• Progression of disease defined by one of the following occurring within 6 months of study entry:
• At least a 20% increase in radiologically or clinically measurable disease;
• Appearance of any new lesion;
• Symptomatic disease (including worsening hormonal symptoms or symptoms related to tumor burden);
• Overexpression of somatostatin receptors of the target lesions at 68Ga-DOTATATE PET/CT with SUV of lesions greater than normal liver at least in 1 metastasis.
• ECOG performance status 0 or 1 (Karnofsky ≥ 70%).
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
• Previous local therapy (e.g., chemoembolization or bland embolization) is allowed if completed >6 weeks prior to study entry. For such patients, there must be either progression of measurable disease documented within the treatment field, or measurable progressive disease outside the treatment field prior to study entry.
• Previous oral chemotherapy, biotherapy (such as Interferons or Everolimus) and/or investigational agents are allowed if completed >4 weeks prior to study entry For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.
• Patients must not be candidate for potentially curative surgery. Prior surgery is allowed no less than 6 weeks prior to study entry. Note: Patients who have disease that is amendable to resection but who are not a surgical candidate for other medical reasons would be permitted.

You may not qualify if…

• Women who are pregnant or breastfeeding
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTATATE as assessed from medical records.
• Life expectancy < 6 months as assessed by the treating physician.
• Over 80% liver involvement by tumor per the judgement of the radiologist
• Poorly differentiated neuroendocrine neoplasms (Neuroendocrine Carcinoma), small and large cell type; Mixed Neuroendocrine-Nonneuroendocrine Neoplasm (MiNEN).
• Presence of somatostatin receptor negative lesions.
• Prior treatment with other radiolabeled somatostatin analogs.
• Prior systemic chemotherapy, except oral chemotherapy with capecitabine + temozolomide
• Contraindication to angiography/embolization including:
• Patients cannot receive contrast
• Severe allergic reaction to contrast despite premedication. Patients in who IV contrast is contraindicated are recommended to have MRI abdomen and noncontrast chest CT scan.
• Poor renal function not on dialysis
• Other, based on judgment of the investigator
• Main portal vein tumor thrombus.
• Deteriorated renal function:
• Serum creatinine >1.7 mg/dL OR
• EGFR <30 ml/min
• Deteriorated bone marrow function:
• Hb <8.0 g/dL;
• WBC <3000/mm3;
• ANC<1500/mm3;
• Platelets <75.000/mm3
• Deteriorated liver function:
• INR > 2.0 for patients that are not on Coumadin or Xarelto
• PTT > 2x ULN

Where it is running

• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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