Combining Decitabine and Selinexor with Standard Chemotherapy for Ovarian Cancer
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
PHASE2 · Loyola University · NCT05983276
This study is testing a new combination of chemotherapy drugs, including decitabine and selinexor, to see if it helps women with relapsed ovarian cancer feel better and stay in remission longer.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Loyola University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Maywood, Illinois) |
| Trial ID | NCT05983276 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with relapsed or refractory epithelial ovarian cancer who have previously failed platinum and taxane-based therapies.
Not a fit: Patients with non-epithelial ovarian cancers or those who have not received prior platinum and taxane treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with drug-resistant ovarian cancer.
How similar studies have performed: While the combination of these specific agents is investigational, similar approaches have shown promise in reversing drug resistance in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Maywood, Illinois
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Platinum Resistance, Relapsed/Refractory Epithelial, Fallopian Tube, Primary Peritoneal Cancer