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

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Loyola University
Study ID
NCT05983276
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Decitabine — DRUG
    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 — DRUG
    Carboplatin is classified as an alkylating agent that is used to treat ovarian cancer.
  • Paclitaxel — DRUG
    Paclitaxel is classified as a "plant alkaloid," a "taxane" and an "antimicrotubule agent."
  • Selinexor — DRUG
    Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by killing cancer cells.

Study Details

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.

Key Dates

Start date
Nov 16, 2023
Status verified
Feb 2024
Primary completion
Aug 28, 2030
Completion
Aug 28, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Loyola University Medical CenterMaywoodIllinois60153
Patrick Stiff, MD
[email protected]
708-327-3148
Jennifer Guevara, RN
[email protected]
708-327-3239
Ronald Potkul, MD (SUB_INVESTIGATOR)
Margaret Liotta, MD (PRINCIPAL_INVESTIGATOR)
Abigal Winder, MD (SUB_INVESTIGATOR)

Find similar trials in Maywood, IL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Loyola University Medical Center· Maywood, IL

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