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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

losartan
Drug
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.
Paclitaxel
Drug
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.

Treatment groups

27 Participants

are divided into 1 treatment group

Group A: Losartan + PaclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Overall Response Rate (ORR)

ORR will be determined as the number of patients with a partial response (PR) or complete response (CR) to therapy by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.

Time frame

Screening through end of treatment, estimated 24 months total.

Secondary outcomes

Progression free survival (PFS)

The time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Response is evaluated using RECIST 1.1.

Time frame

Screening through end of treatment, estimated 24 months total

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

American Cancer Society, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: