Recruiting
Phase 2

Decitabine & Selinexor

Sponsor:

Loyola University

Code:

NCT05983276

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Decitabine

Carboplatin

Paclitaxel

Selinexor

Study Details

Brief summary:

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.

Conditions

Ovarian Cancer

Study ID

NCT05983276

Start date

Nov 16, 2023

Status verified date

Feb, 2024

Completion date

Aug 28, 2031

Anticipated

Primary completion date

Aug 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Decitabine / Selinexor/ Carboplatin / Paclitaxel

C1:

Days 1-5: Decitabine 10 mg/m2 IV daily Day 6: carboplatin AUC 5 and paclitaxel 80 mg/ m2 Days 13, 20, and 27: paclitaxel 80 mg/m2 For a single 28 day cycle

Assess Response toxicities and immune effector cell changes

C2-C6:

Days 1-5: Decitabine 10 mg/m2 IV daily Day 6: carboplatin AUC 5 and paclitaxel 80 mg/ m2 Day 7 and weekly thereafter (day 14, 21, 28, 35...) Selinexor 60 mg PO Days 13, 20, and 27: paclitaxel 80 mg/m2 each given x five 28 day cycles

Assess responses by exam, CT scan and blood tests, assess toxicities, and immune effector cell changes as well as progression and overall survival

Interventions

Decitabine

Decitabine is classified as hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow.

Carboplatin

Carboplatin is classified as an alkylating agent that is used to treat ovarian cancer.

Paclitaxel

Paclitaxel is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent."

Selinexor

Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by killing cancer cells.

Primary outcome measure

  • 40 participants evaluated for safety with treatment-related adverse events and grading using CTCAE 4.3. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Patrick Stiff, MD

708-327-3148pstiff@lumc.edu

Agnes Natonton, RN

708-327-3383anatont@luc.edu

Locations

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Patrick Stiff, MD

708-327-3148pstiff@lumc.edu

Jennifer Guevara, RN

708-327-3239jguevara@luc.edu

Principal Investigator:

Margaret Liotta, MD

More Information

Sponsor

Loyola University

Last update posted

Feb 8, 2024

Last verified

Feb, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2024-02-08.