This phase II trial tests the safety and effectiveness of nab-sirolimus plus fulvestrant for treating low grade serous ovarian cancer that has come back after a period of improvement (recurrent). Sirolimus is a kinase inhibitor. It blocks the activity of certain pathways in the body that may cause a decrease in tumor cell multiplication. Nab-sirolimus is an albumin-stabilized nanoparticle formulation of sirolimus, which may have fewer side effects and work better than other forms of sirolimus. Fulvestrant is a type of hormone therapy. It binds to estrogen receptors, resulting in estrogen receptor deformation and decreased estrogen binding. Nab-sirolimus is approved for the treatment of other types of cancer and fulvestrant is approved for the treatment of breast cancer, but neither of these drugs are approved for the treatment of ovarian cancer. The combination of these drugs may be a safe and effective treatment option for patients with recurrent low grade serous ovarian cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06494150.
Locations matching your search criteria
United States
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences CenterStatus: Active
Contact: Christina Washington
Phone: 405-271-8707
PRIMARY OBJECTIVES:
I. To determine the objective response rate (ORR) of sirolimus albumin-bound nanoparticles (nab-sirolimus) and fulvestrant in patients with recurrent low grade serous ovarian cancer (LGSOC).
II. To establish the toxicity profile of nab-sirolimus and fulvestrant in patients with recurrent LGSOC.
SECONDARY OBJECTIVES:
I. To determine the rate of progression-free survival (PFS) at 6 months among patients with recurrent LGSOC receiving nab-sirolimus and fulvestrant.
II. To determine the duration of response (DOR) of nab-sirolimus and fulvestrant in patients with recurrent LGSOC.
EXPLORATORY TRANSLATIONAL OBJECTIVE:
I. To identify genetic mutations in LGSOC tumors that predict patient response to nab-sirolimus + fulvestrant, with a specific focus on genes encoding ERα, raptor and other mTOR1 complex proteins, and RAS/RAF proteins.
OUTLINE:
Patients receive nab-sirolimus intravenously (IV) over 30 minutes on days 1 and 8 of each cycle and fulvestrant intramuscularly (IM) over 1-2 minutes on days 1 and 15 of cycle 1 and then once every 21 days thereafter. Cycles repeat every 21 days for approximately 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) throughout the trial. Patients may undergo biopsy at baseline.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Lead OrganizationUniversity of Oklahoma Health Sciences Center
Principal InvestigatorChristina Washington