Phase II Study of Nab-sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer
University of Oklahoma
Summary
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).
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have a histologic confirmed low-grade serous ovarian cancer with clinical evidence of reoccurrence. 2. All patients must have measurable disease as defined by RECIST version 1.1. 3. ECOG Performance status must be 0-1. 4. Adequate bone marrow, hepatic and renal function as defined by the protocol. 5. At least 4 weeks must have elapsed since the patient underwent any major surgery. 6. At least 2 weeks must have elapsed since the patient received any radiation therapy. 7. Patients must have signed an IRN approved informed consent and authorization permitting…
Interventions
- Drugnab-Sirolimus
nab-Sirolimus will be administered by intravenous infusion at 100mg/m2 on days 1 and 8 of each 21-day cycle
- DrugFulvestrant
Fulvestrant will be administered by intramuscular injection at 500mg on days 1 and 15 of cycle 1 and then every 21 days
Location
- OU Health Stephenson Cancer CenterOklahoma City, Oklahoma