A Phase 2 Study of Losartan in Combination With Weekly Paclitaxel in Platinum Resistant Ovarian Cancer
Massachusetts General Hospital
Summary
The purpose of this Phase II study is to measure the effects of a combination of study drugs, losartan and paclitaxel, on platinum resistant ovarian cancer.
Description
This is a prospective, single-arm, open label study of daily oral losartan in combination with intravenous weekly paclitaxel in patients with platinum resistant ovarian cancer. The primary endpoint of this study is overall response rate (ORR) and the secondary endpoint is progression free survival. The U.S. Food and Drug Administration (FDA) has not approved losartan for this specific disease but it has been approved for other uses. The U.S. Food and Drug Administration (FDA) has approved paclitaxel as a treatment option for this disease. This research study involves screening for eligibility…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * The subject must be 18 years of age. * Subjects with histologically/cytologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Subjects with mucinous carcinoma and low-grade serous carcinoma are not eligible. * Participants 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 (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.…
Interventions
- Druglosartan
Treatment with losartan will be administered orally once daily starting on day 1 of every 21-day cycle and will be taken continuously throughout the cycle. Losartan is administered at 25 mg a day for the first 7 days of cycle 1. Losartan may be increased to 50 mg daily on day 8 if systolic blood pressure ≥ 120 mm Hg.
- DrugPaclitaxel
Paclitaxel 80 mg/m2 will be administered as a 60-min intravenous infusion after any premedication as per institutional guidelines. A ramp-up infusion rate is also acceptable as per institutional guidelines. Paclitaxel will be administered on days 1, 8 and 15 of a 21-day cycle and treatment will continue until unacceptable toxicity or disease progression.
Location
- Massachusetts General HospitalBoston, Massachusetts