RECRUITING

Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn about the side effects and effectiveness of this novel four-drug combination of chemotherapy (decitabine, selinexor, carboplatin and paclitaxel) on patients with relapsed ovarian, fallopian or primary peritoneal carcinoma. Recently the investigators have found that the combination of decitabine and selinexor, two Food and Drug Administration (FDA) approved chemotherapy agents, may prevent or reverse the development of drug resistance and further the remissions and duration of remissions with standard ovarian cancer chemotherapy with carboplatin and paclitaxel. As decitabine and selinexor are not FDA approved for the participant's cancer, these agents are investigational.

Official Title

Combination of the Hypomethylating Agent Decitabine and the Nuclear Export Receptor XPO-1 Inhibitor Selinexor to Reverse Platinum Resistance in Relapsed/Refractory Epithelial Ovarian Cancer

Quick Facts

Study Start:2023-11-16
Study Completion:2031-08-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05983276

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be greater than or equal to 18 years of age
  2. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status PS less than or equal to 2.
  3. * Participants must have histological or cytological proven epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma with relapse or disease progression after prior treatment by exam, computed tomography (CT), PET/CT, or magnetic resonance imaging (MRI) may be enrolled. All cell types including clear cell carcinoma are eligible.
  4. * Participants must have failed or relapsed after a platinum and taxane containing combination
  5. * Participants must have adequate hepatic function
  6. * Participants must have adequate renal function
  7. * Participants must be able to swallow and retain oral medications
  8. * Participants must have measurable disease according to Gynecologic Cancer Intergroup CA125 criteria
  9. * Participants with stable (for 2 months or longer), treated (by radiotherapy) CNS metastases are eligible
  10. * Participants with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B has been given for greater than 8 weeks.
  1. * Participants must not have received Selinexor or another XPO1 inhibitor previously.
  2. * Participants must not have had any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.)
  3. * Participants must not have uncontrolled active infection. Participants on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
  4. * Participants must not have known intolerance, hypersensitivity, or contraindication to platinum or taxane therapy
  5. * Participants must not have active, unstable cardiovascular function
  6. * Participants must not have myocardial infarction within 3 months prior to starting
  7. * Participants with untreated central nervous system (CNS) metastases are ineligible.
  8. * Participants must not have had prior chemotherapy or radiation therapy
  9. * Participants must not have DVT related to metastatic disease requiring ongoing anticoagulation.

Contacts and Locations

Study Contact

Patrick Stiff, MD
CONTACT
708-327-3148
pstiff@lumc.edu
Agnes Natonton, RN
CONTACT
708-327-3383
anatont@luc.edu

Principal Investigator

Patrick L Stiff, MD
PRINCIPAL_INVESTIGATOR
Loyola University

Study Locations (Sites)

Loyola University Medical Center
Maywood, Illinois, 60153
United States

Collaborators and Investigators

Sponsor: Loyola University

  • Patrick L Stiff, MD, PRINCIPAL_INVESTIGATOR, Loyola University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-16
Study Completion Date2031-08-28

Study Record Updates

Study Start Date2023-11-16
Study Completion Date2031-08-28

Terms related to this study

Keywords Provided by Researchers

  • Ovarian Cancer
  • Platinum Resistance
  • Relapsed/Refractory Epithelial
  • Fallopian Tube
  • Primary Peritoneal Cancer

Additional Relevant MeSH Terms

  • Ovarian Cancer