Actively Recruiting
Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors
Led by University of Chicago · Updated on 2026-01-09
25
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pancreatic neuroendocrine tumor, WHO grades 1-2, Ki-67 index <20%.
- Locally advanced disease not suitable for curative surgery or metastatic disease.
- Measurable disease with lesions at least 20 mm by conventional methods or 10 mm by advanced imaging.
- Tumors must express somatostatin receptor as shown by a prior DOTATATE PET scan.
- Radiographic progression on one or more prior systemic therapies, including somatostatin analogs, chemotherapy, or targeted therapies.
- No prior systemic therapy with peptide receptor radionuclide therapy or Fulvestrant.
- Previous hepatic embolic or ablation therapies allowed if recovered and lesions meet criteria.
- Stable use of somatostatin analog therapy allowed under specified conditions.
- Age 18 years or older.
- ECOG performance status of 0 or 1.
- Adequate organ and marrow function with specified blood counts and lab values.
- HIV patients on effective treatment with undetectable viral load within 6 months.
- Controlled hepatitis B or treated hepatitis C infection.
- No other active malignancies or treated brain metastases stable for at least 3 months.
- Cardiac function classified as NYHA class 2B or better.
- Not pregnant or nursing, with negative pregnancy test for women of childbearing potential.
- Life expectancy greater than 12 weeks.
- Ability and willingness to provide informed consent.
You will not qualify if you...
- Inability to provide or understand informed consent or comply with study procedures.
- Receiving any other investigational agents.
- Active second malignancy other than certain skin cancers unless disease-free for 3 years.
- Pregnant or breastfeeding.
- Signs of imminent organ failure.
- Known untreated brain metastases due to poor prognosis and risk of neurologic issues.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Clinical Trials Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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