Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04086485
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Lu-177-DOTATATE — DRUG
    Lu-177-DOTATATE will be given by IV every 8 (+/-2) weeks for a total of 4 administrations
  • Olaparib — DRUG
    Olaparib is given as a pill taken orally and is to be taken twice a day, starting from 2 days before the first administration of Lu-177-DOTATATE until 4 weeks after the last administration
  • Ga dotatate scanning — DIAGNOSTIC_TEST
    Ga68-DOTATATE PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.
  • FDG-PET scanning — DIAGNOSTIC_TEST
    F18-FDG PET/CT scan will be done at baseline, at week 32, then every 24 weeks in followup period.
  • Amino Acid infusion — DRUG
    Concomitant administration of an IV infusion of an amino acid (AA) solution will also be done for renal protection. The AA infusion will begin at least 30-60 minutes prior to injection of Lu-177-DOTATATE and will continue during and after the Lutathera infusion until the entire prescribed amount is infused.

Study Details

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.

Key Dates

Start date
Oct 3, 2022
Status verified
Dec 2025
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Lu-177-DOTATATE + Olaparib escalation
    Lu-177-DOTATATE and escalating doses of olaparib to determine the maximum-tolerated dose (MTD)
  • Experimental: 2/Lu-177-DOTATATE + Olaparib fixed dose
    Lu-177-DOTATATE and olaparib at the MTD

Primary Outcome Measure

Phase 1: Maximum Tolerated Dose [ Time Frame: End of cycle 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By condition
Neuroendocrine tumors
By specialty
Oncology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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