This single arm phase II study proposes to evaluate the efficacy and safety of nab-sirolimus + endocrine therapy (Fulvestrant) in patients with recurrent low grade serous ovarian cancer (LGSOC).
Patients with histologic confirmed Low Grade Serous Ovarian Cancer with measurable disease should have a pre-dose tumor biopsy. Patients will receive proposed treatment regimen of nab-sirolimus on days 1 and 8 and fulvestrant on days 1 and 15 of cycle 1 and then every 21-day cycle as long as there is evidence that tumor is not growing or spreading and they are not having any unacceptable, bad side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
nab-Sirolimus will be administered by intravenous infusion at 100mg/m2 on days 1 and 8 of each 21-day cycle
Fulvestrant will be administered by intramuscular injection at 500mg on days 1 and 15 of cycle 1 and then every 21 days
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
RECRUITINGThe percentage of people in a treatment group who have a partial or complete response to the treatment within a certain period of time as measured by RECIST version 1.1.
The primary analysis is preplanned to occur when the last patient enrolled has been treated for 6 months.
Time frame: 3 years
Incidence of patients with ≥ grade 3 adverse events.
Review of adverse events that have occurred to determine the toxicity for the proposed treatment regimen.
Time frame: 3 years
Proportion of patients who have remained progression-free for 6-months.
Proportion of patients on the proposed treatment combination who have not had any disease progression for at least 6 months.
Time frame: 3 years
Duration of response from a subjects first scan to disease progression or death.
Determine the length of time from the date subjects have partial or complete response to treatment until the date the subjects have disease progression.
Time frame: Up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.