Losartan and Paclitaxel in Platinum Resistant Ovarian Cancer
ConditionPlatinum Resistant Ovarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Subject is able to provide written, informed consent before initiation of any study related procedures, and is able, in the opinion of the investigator, to comply with all the requirements of the study.
Disqualifiers
Has adverse events (AEs) from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except alopecia.
Subjects with asymptomatic central nervous system (CNS) metastases are eligible provided they have been clinically stable and not requiring steroid for at least 4 weeks.
Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 3 months.
Impaired cardiac function or clinically significant cardiac disease.
Trial design
Treatments tested in this trial
- losartan
- Paclitaxel
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov