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

  • STATUS
    Recruiting
  • End date
    Sep 22, 2023
  • participants needed
    10
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 22 March 2022

Summary

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.

Details
Condition Neuroendocrine Tumors, Liver-Dominant Metastatic Pancreatic Neuroendocrine Tumors
Treatment 177Lu-Dotatate
Clinical Study IdentifierNCT04544098
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
ECOG performance status 0 or 1 (Karnofsky ≥ 70%)
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

Exclusion Criteria

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
Total bilirubin >3 mg/dl
Serum albumin <3.0 g/dL unless prothrombin time is within the normal range
Previous liver radioembolization with 90Y-microspheres
Clinically relevant toxicities from prior therapies that have not resolved to grade 1
Known brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized
or grade 0
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
Uncontrolled diabetes mellitus
Prior external beam radiation therapy involving >25% of the bone marrow
Inability to interrupt short-acting Octreotide for 24 h before and 24 h after the administration of 177Lu-DOTATATE; inability to have an interval between Octreotide LAR and 177Lu-DOTATATE of ≥4 weeks
Unmanageable urinary incontinence rendering the administration of 177Lu-DOTATATE unsafe
Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence
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