Combining Decitabine and Selinexor with Standard Chemotherapy for Ovarian Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and side effects of a novel combination of chemotherapy drugs, including decitabine, selinexor, carboplatin, and paclitaxel, in patients with relapsed ovarian, fallopian tube, or primary peritoneal carcinoma. Participants will receive decitabine followed by standard doses of carboplatin and paclitaxel, with selinexor added in subsequent cycles if tolerated. The treatment will be administered in an outpatient setting, with regular assessments to monitor progress and response to therapy. The goal is to prevent or reverse drug resistance and enhance remission duration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants must be greater than or equal to 18 years of age
* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status PS less than or equal to 2.
* 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.
* Participants must have failed or relapsed after a platinum and taxane containing combination
* Participants must have adequate hepatic function
* Participants must have adequate renal function
* Participants must be able to swallow and retain oral medications
* Participants must have measurable disease according to Gynecologic Cancer Intergroup CA125 criteria
* Participants with stable (for 2 months or longer), treated (by radiotherapy) CNS metastases are eligible
* Participants with active hepatitis B virus (Hep B) are allowed if antiviral therapy for hepatitis B has been given for greater than 8 weeks.

Exclusion Criteria:

* Participants must not have received Selinexor or another XPO1 inhibitor previously.
* Participants must not have had any concurrent medical condition or disease (eg, uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.)
* Participants must not have uncontrolled active infection. Participants on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.
* Participants must not have known intolerance, hypersensitivity, or contraindication to platinum or taxane therapy
* Participants must not have active, unstable cardiovascular function
* Participants must not have myocardial infarction within 3 months prior to starting
* Participants with untreated central nervous system (CNS) metastases are ineligible.
* Participants must not have had prior chemotherapy or radiation therapy
* Participants must not have DVT related to metastatic disease requiring ongoing anticoagulation.

Where it's running

• Loyola University Medical Center
  Maywood, Illinois, United States Recruiting

Study contacts

• Principal investigator: Patrick L Stiff, MD — Loyola University
• Study coordinator: Patrick Stiff, MD
• Email: pstiff@lumc.edu
• Phone: 708-327-3148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.