Study on Decitabine and Selinexor with Standard Chemotherapy to Overcome Drug Resistance in Ovarian Cancer

Sponsor: Loyola University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05983276

Provider View

This clinical trial is exploring a new combination of four drugs to see if it can help treat ovarian, fallopian tube, or primary peritoneal cancer that has returned after previous treatment. The study aims to find out if adding decitabine and selinexor to standard chemotherapy can prevent or reverse drug resistance.

Patient Parameters

Program Overview

The purpose of this study is to test the safety and effectiveness of a new treatment combination for ovarian cancer that has come back after treatment. The treatment includes two FDA-approved drugs, decitabine and selinexor, along with standard chemotherapy drugs carboplatin and paclitaxel. Researchers believe that decitabine and selinexor may help prevent or reverse resistance to chemotherapy, potentially leading to longer remissions. However, these drugs are not yet approved for this specific type of cancer, so they are considered investigational in this study.

Description

Participants in this study will start with a treatment cycle that includes decitabine, followed by carboplatin and paclitaxel. If this is well-tolerated, selinexor will be added in the second cycle. Each cycle lasts 28 days and is done on an outpatient basis. During the first cycle, participants will receive decitabine for 5 days, with carboplatin and paclitaxel on the 6th day. Paclitaxel will continue weekly for 3 weeks. Each decitabine session lasts about 1 hour, while carboplatin and paclitaxel take about 4 hours, and paclitaxel alone takes 1 hour. Selinexor is introduced in the second cycle and is taken orally once a week. Participants will have weekly clinic visits during the first two cycles. If the treatment is effective and remission is achieved, participants may continue for up to 6 cycles.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Must have a confirmed diagnosis of epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has returned or progressed after previous treatment.
  • Must have previously been treated with a combination of platinum and taxane drugs.
  • Must have adequate liver and kidney function.
  • Must be able to swallow pills.
  • Must have measurable cancer according to specific criteria.
  • Can have stable, treated brain metastases.
  • Can have active hepatitis B if they have been on antiviral treatment for more than 8 weeks.

Exclusion Criteria

  • Must not have previously received Selinexor or similar drugs.
  • Must not have uncontrolled medical conditions like high blood pressure or diabetes.
  • Must not have an active, uncontrolled infection.
  • Must not have allergies or contraindications to platinum or taxane chemotherapy.
  • Must not have unstable heart conditions or recent heart attacks.
  • Must not have untreated brain metastases.
  • Must not have had prior chemotherapy or radiation therapy for this cancer.
  • Must not have blood clots related to cancer that require ongoing blood thinners.

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