Actively Recruiting
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
Led by National Cancer Institute (NCI) · Updated on 2026-04-07
56
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: A neuroendocrine tumor is a rare type of tumor. It comes from body cells called neuroendocrine cells. Sometimes, these tumors develop in the gastrointestinal tract and pancreas. Researchers want to find out if a combination of drugs can shrink these tumors. Objective: To learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lutathera and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. Eligibility: Adults 18 and older who have a neuroendocrine tumor in the pancreas or intestine that cannot be cured by surgery and has somatostatin receptors on the cells. Design: Eligible participants will get Lutathera through an intravenous (IV) infusion every 8 weeks for 4 cycles. One cycle is 8 weeks. Each cycle includes a follow-up visit at week 4. For the IV, a small plastic tube is put into an arm vein. Participants will also take Olaparib by mouth twice a day for 4 weeks of each cycle. They will use a medicine diary to track the doses. During the study, participants will have physical exams. They will have blood and urine tests. They will fill out questionnaires about their general well-being and function. Their heart function will be tested. They will have scans of their chest, abdomen, and pelvis. One type of scan will use an IV infusion of a radioactive tracer. Participants will have a follow-up visit about 4 weeks after treatment ends. Then they will have follow-up visits every 12 weeks for 3 years. Then they will have yearly phone calls.
CONDITIONS
Official Title
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of gastroenteropancreatic neuroendocrine tumor confirmed by tissue analysis
- Disease that cannot be cured by surgery due to spread or involvement of critical structures
- Adults aged 18 years or older
- Positive somatostatin receptor status confirmed by Ga-68-DOTATATE PET scan within 12 weeks
- ECOG Performance Status of 0 or 1 indicating good physical functioning
- Stable dose of somatostatin analogue therapy for at least 3 months if applicable
- Normal organ and bone marrow function within 28 days prior to enrollment
- Willingness and ability to sign informed consent
- For individuals who can bear children: negative pregnancy test within 28 days and agreement to use effective contraception or remain abstinent during and after treatment
- Ability to have a medical specialist follow-up after treatment
You will not qualify if you...
- Tumors that are negative on Ga-68-DOTATATE PET but positive on FDG-PET unless prior progression on treatment
- Breastfeeding mothers
- Other active cancers except certain skin cancers or fully treated cervical cancer within 5 years
- Use of other investigational drugs
- Recent systemic chemotherapy or radiotherapy within 4 weeks except palliative care
- Persistent moderate or severe side effects from prior cancer therapies that interfere with treatment
- Weight exceeding 400 pounds (PET table limit)
- Uncontrolled illnesses such as infections, heart failure, unstable angina, high blood pressure, arrhythmias, or psychiatric conditions
- Symptomatic or untreated brain metastases
- Spinal cord compression without stable disease after treatment
- Use of strong/moderate CYP3A inhibitors or inducers shortly before enrollment
- Major surgery within 4 weeks not fully recovered
- Inability to swallow oral medication or gastrointestinal issues affecting absorption
- Previous allogeneic stem cell or bone marrow transplant
- Known allergy to study drugs or their ingredients
- Uncontrolled heart conditions or prolonged QT interval
- Blood disorders like myelodysplastic syndrome or leukemia
- Immunocompromised status such as HIV infection
- Active hepatitis B or C infection
- Prior treatment with PARP inhibitors or Lu-177-DOTATATE
- Involvement in the planning or conduct of this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Joy H Zou, R.N.
CONTACT
F
Frank I Lin, M.D.
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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