Study on Losartan and Paclitaxel for Treating Platinum-Resistant Ovarian Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07265739

Provider View

This clinical trial is exploring the effects of combining two drugs, losartan and paclitaxel, to treat ovarian cancer that has not responded to platinum-based treatments. The study aims to see if this combination can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

The purpose of this Phase II study is to test if a combination of the drugs losartan and paclitaxel can effectively treat ovarian cancer that is resistant to platinum-based chemotherapy. Losartan is not yet approved for this specific use, but paclitaxel is an approved treatment for this type of cancer. Participants will receive these drugs until the cancer progresses, they choose to stop, or they experience unacceptable side effects. The study will involve regular visits and tests to monitor the effects of the treatment. About 27 people are expected to participate.

Description

This study involves taking losartan orally every day and receiving paclitaxel through an IV once a week. The main goal is to see how well the cancer responds to this treatment combination. Researchers will also look at how long patients can go without the cancer getting worse. Participants will be screened to ensure they meet the study criteria, and they will continue treatment until the cancer progresses, they withdraw, or they experience side effects that are too severe. If the cancer progresses, participants will be followed for 30 days. If they stop due to side effects, they will have check-ups and scans every 9 weeks until they start a new treatment. The study is open to about 27 participants.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have advanced ovarian, fallopian tube, or primary peritoneal cancer confirmed by lab tests. Mucinous and low-grade serous carcinoma are not eligible.
  • Have at least one tumor that can be measured accurately.
  • Able to provide written consent and follow study requirements.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have adequate organ function based on specific blood tests.
  • Must be at least 4 weeks from the last biologic or immunotherapy and 2 weeks from the last chemotherapy.
  • Have ovarian cancer that returned less than 6 months after platinum treatment or did not respond to initial platinum treatment.
  • Have received no more than 4 prior treatments for platinum-resistant ovarian cancer.
  • Must have tried other treatments like bevacizumab or PARP inhibitors if eligible, or have documented reasons for not receiving them.

Exclusion Criteria

  • Have unresolved side effects from previous cancer treatments, except hair loss.
  • Have serious health conditions that could interfere with the study, like heart or lung problems.
  • Have active infections or a history of hepatitis B or C.
  • Have received a live vaccine within 30 days before starting the study.
  • Are pregnant or breastfeeding.
  • Have severe allergies to paclitaxel.
  • Have significant nerve damage or high blood pressure issues.
  • Have a history of fainting or low blood pressure.
  • Have uncontrolled high blood pressure.
  • Have any other serious health conditions that could affect participation in the study.

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