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Decitabine and Selinexor with Chemotherapy for Ovarian Cancer

This study is testing a new combination of medicines for people with ovarian, fallopian tube, or primary peritoneal cancer that has come back or gotten worse after previous treatment. We want to see how safe and effective a four-drug combination is: decitabine, selinexor, carboplatin, and paclitaxel. Decitabine and selinexor are being studied because they might help prevent or reverse drug resistance to standard chemotherapy (carboplatin and paclitaxel). You could be eligible if you are at least 18 years old and meet certain health criteria. The main goal is to understand the side effects of this treatment over 6 months. The study aims to enroll 40 participants.

Study design
This is an interventional study, meaning participants will receive the study treatments. It plans to enroll 40 participants.
What's involved
You will receive decitabine for 5 days, followed by carboplatin and paclitaxel on day 6. Paclitaxel will continue weekly for 3 weeks. Selinexor is added from the second cycle, given weekly. You will have weekly clinic visits for the first two cycles and up to 9 study visits per cycle.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be evaluated for 6 months after starting treatment.

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NCT05983276

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Loyola University
~40 participants
Updated 2024-02-08 on ClinicalTrials.gov
What's tested:DecitabineCarboplatinPaclitaxelSelinexor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
40 participants evaluated for safety with treatment-related adverse events and grading using CTCAE 4.3.
Measured over 6 months

Conditions

Ovarian Cancer

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal Cancer

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Patrick L Stiff, MD · PRINCIPAL_INVESTIGATOR · Loyola University

Who to contact

Patrick Stiff, MD
[email protected]
708-327-3148
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 40 participants evaluated for safety with treatment-related adverse events and grading using CTCAE 4.3.6 months

    To determine the safety of two agents in combination to reverse platinum resistance in ovarian cancer: the hypomethylating agent, decitabine, and the nuclear export receptor XPO1 inhibitor, selinexor, combined with carboplatin and paclitaxel in patients with relapsed/refractory epithelial ovarian carcinoma