Study on Fulvestrant and Abemaciclib for Women with Advanced Low-Grade Serous Ovarian Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03531645

Provider View

This clinical trial is exploring whether the combination of fulvestrant and abemaciclib can effectively manage low-grade serous ovarian cancer in women. The study also aims to assess the safety of this drug combination.

Patient Parameters

Program Overview

The purpose of this study is to find out if using the drugs fulvestrant and abemaciclib together can help control low-grade serous ovarian cancer. Both drugs are already approved for treating other types of cancer, but their use for this specific type of ovarian cancer is still being researched. Up to 15 women will participate in this study, which will take place at MD Anderson.

Description

Study Drug Administration

The study is divided into two treatment periods: before surgery (Neoadjuvant Treatment) and after surgery (Adjuvant Treatment). Each treatment cycle lasts 28 days.

  • Neoadjuvant Treatment (Cycles 1-4):

    • If you are premenopausal or perimenopausal, you will receive goserelin injections every 12 weeks.
    • You will receive fulvestrant injections on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2-4.
    • You will take abemaciclib tablets twice daily from Days 1 to 28 of each cycle.

  • Surgery:

    • After 4 cycles, you will have surgery as part of your standard care.

  • Adjuvant Treatment (Cycles 5 and beyond):

    • After recovering from surgery, you will continue receiving fulvestrant injections on Day 1 of each cycle and take abemaciclib tablets twice daily.

You will receive standard medications to help reduce side effects. The study will continue as long as it is beneficial for you, unless the cancer worsens, side effects become intolerable, or you cannot follow the study directions.

Study Visits

  • On Day 1 of each cycle, you will have a physical exam, blood tests, and urine tests. If you can become pregnant, a pregnancy test will be included.
  • On Day 15 of Cycle 1, you will have another physical exam.
  • On Day 1 of odd-numbered cycles after Cycle 1, you will have an MRI or CT scan.
  • Before surgery, you will have a CT scan or MRI to check the cancer's status.
  • During surgery, some tissue will be collected for research purposes.

End-of-Treatment Visit

  • After your last dose of the study drugs, you will have a physical exam, blood tests, and an MRI or CT scan.

Follow-Up

  • About 30 days after your last dose, the study staff will call you to check on your well-being. This call will take about 5 minutes.

Eligibility Criteria

Inclusion Criteria

  • Women with advanced low-grade serous ovarian, primary peritoneal, or fallopian tube cancer who are recommended for neoadjuvant therapy.
  • Cancer diagnosis confirmed by surgery or biopsy.
  • Willing to provide tissue samples for research.
  • Signed informed consent.
  • Measurable disease by standard criteria.
  • Women aged 18 or older.
  • Good overall health with a performance status of 0-1.
  • Acceptable blood counts and organ function.
  • Negative pregnancy test for women of childbearing potential.
  • Willing to use effective birth control during the study.
  • Premenopausal women must be willing to receive goserelin treatment.
  • Ability to understand and sign informed consent.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Serious preexisting medical conditions that prevent participation.
  • Use of certain medications that interact with the study drugs.
  • Recent diagnosis of another cancer, except for certain skin or cervical cancers.
  • Previous treatment for ovarian cancer.
  • Known infections like Hepatitis B, C, or HIV.
  • Difficulty swallowing pills.
  • Active infections requiring IV antibiotics.
  • Inability to follow study procedures.
  • History of certain heart conditions.
  • Previous stem cell or bone marrow transplant.
  • Blood clotting disorders that prevent injections.
  • Allergies to study drugs or their components.

Locations

FACILITYZIPCITYSTATE
University of Texas MD Anderson Cancer Center77030HoustonTexas

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