A Phase I Study of Fulvestrant in Combination With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors
University of Chicago
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.
Description
Patients with metastatic pancreatic neuroendocrine tumors (pNETs) suffer from a diminished lifespan. Newer therapies such as Peptide Receptor Radionuclide Therapy (PRRT), using 177Lu-DOTATATE, have aimed to improve survival in metastatic NETs, but result in palliation rather than cure. Combining radioligand therapies (RLT) with radiosensitizers has not been widely explored in the clinical setting, but encouraging pre-clinical data makes this a sensible approach. In this study the investigators will assess the safety combining 177Lu-DOTATATE in combination with Fulvestrant in patients with pan…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically confirmed pancreatic neuroendocrine tumor, WHO grades 1-2, Ki-67 index of \<20%. * Patients must have locally advanced disease that is ineligible for curative-intent resection, or metastatic disease. * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. * Patients mu…
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.
Location
- University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois