A new clinical trial at the University of Chicago Medicine is evaluating the combination of 177Lu-DOTATATE with fulvestrant in patients with advanced pancreatic neuroendocrine tumors (pNETs). This phase I, open-label study aims to assess the safety and preliminary tumor response of the investigational treatment combination.
Fulvestrant is a hormone therapy used to treat certain kinds of breast cancer. It works by blocking estrogen receptors on cancer cells, slowing or stopping the growth of tumors that depend on estrogen.
177Lu-DOTATATE is a type of peptide receptor radionuclide therapy, or PRRT. It treats neuroendocrine cancer by converting a cancer cell’s unique characteristics into a welcome mat for a “Trojan Horse” packed with cancer-killing radiation. The therapy was approved for use in the United States in January 2018.
In the first stage of the clinical trial, the investigators will evaluate the safety and tolerability of the treatment in 6-12 participants who complete at least 28 days of safety follow-up after their first dose. If no significant safety issues are observed, the trial will proceed to the second stage – a dose-expansion phase in an additional 13 participants.
The clinical trial builds upon NETRF-supported research funding to Xavier Keutgen, MD, an endocrine and neuroendocrine surgeon at the University of Chicago Medicine. As part of his research project, Dr. Keutgen and his colleagues have investigated whether inhibiting estrogen signaling with fulvestrant enhances the effects of radiation therapy in preclinical NET models. Since the preliminary results from these studies were encouraging, the research team sought additional funding from the University of Chicago Comprehensive Cancer Center for a Phase 1 clinical trial, which was awarded last fall. The trial is now open for recruitment.
“This is a prime example of a translational success story. With the help of NETRF, we were able to generate the preliminary data needed to confirm our hypothesis and apply for funding to open a clinical trial,” says Dr. Keutgen. “Although we have yet to confirm that the preclinical findings translate into our patient population, the speed by which we were able to proceed to bring this combination therapy to the clinic has been exemplary.”
Inclusion and Exclusion Criteria
The clinical trial, which is led by Chih-Yi (Andy) Liao, MD, a medical oncologist and co-director of the Neuroendocrine Tumor Program at the University of Chicago Medicine, has specific inclusion and exclusion criteria.
Next Steps
Additional information on the study can be found at clinicaltrials.gov. Interested participants should talk to their treatment team about eligibility and determine if the study is aligned with their treatment goals.