RecruitingPhase 1NCT06663072

Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors

A Phase I Study of Fulvestrant in Combination With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors


Sponsor

University of Chicago

Enrollment

25 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a hormone-blocking drug (fulvestrant, which blocks estrogen receptors) with a radioactive drug called lutetium DOTATATE — which delivers targeted radiation directly to tumor cells — can slow the growth of advanced pancreatic neuroendocrine tumors (a slower-growing type of pancreatic cancer). **You may be eligible if...** - You have a biopsy-confirmed pancreatic neuroendocrine tumor (low to intermediate grade, with a growth rate marker called Ki-67 below 20%) - Your disease is locally advanced or has spread to other organs and is not removable with surgery - Your tumor cells have somatostatin receptors visible on a special PET scan - Your cancer has grown after at least one prior treatment (such as hormone analogs, chemotherapy, or targeted therapy) - You have never received radioactive DOTATATE therapy or fulvestrant before **You may NOT be eligible if...** - You have already received radioactive DOTATATE (PRRT) or fulvestrant - Your tumor does not show up on a somatostatin receptor scan - You have not yet tried any prior treatment for your cancer - Your organ function does not meet required levels - You have other significant health issues that would make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFulvestrant

Safety-Run In: Starting Dose: 500 mg IM on Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses. Dose Expansion: 500 mg IM: Days 1, 15, and 29 of Cycle 1; followed by 500 mg IM on Days 1 and 29 of every cycle thereafter for a total of 9 doses.

DRUG177Lu-DOTATATE

Safety-Run In: Starting Dose: 7.4 GBq (200 mCi) IV every 8 weeks for a total of 4 Cycles Dose Expansion:177Lu-DOTATATE7.4 GBq (200 mCi) IV or 3.7 GBq (100 mCi) IV: IV dose every 8 weeks for a total of 4 Cycles.


Locations(1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States

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NCT06663072


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