Malignant Neoplasms of Female Genital Organs Clinical Trial
Official title:
A Pilot Phase II Study of Neoadjuvant Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
The goal of this clinical research study is to learn if fulvestrant and abemaciclib can help to control low-grade serous ovarian cancer. The safety of this drug combination will also be studied. This is an investigational study. Fulvestrant and abemaciclib are both FDA approved and commercially available for the treatment of several types of cancer. Their use in patients with low-grade serous ovarian cancer is investigational. The study doctor can explain how the study drugs are designed to work. Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.
Study Drug Administration Every study cycle will be 28 days. You will receive treatment in 2 periods: Neoadjuvant Treatment (before surgery) and Adjuvant Treatment (after surgery). If you are premenopausal or perimenopausal, you will receive goserelin as an injection under the skin every 12 weeks. The study doctor will tell you if you will have these injections. Neoadjuvant Treatment (Cycles 1-4) There are 4 cycles in the neoadjuvant treatment period. On Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth at about the same time each day, preferably with food. Abemaciclib should be swallowed whole; not chewed. If a tablet is broken, cracked, or otherwise not whole, do not take it. Surgery After 4 cycles of neoadjuvant treatment, you will have your scheduled surgery as part of your standard care. You will sign a separate consent for this surgery describing the procedure and its risks in more detail. Adjuvant Treatment (Cycles 5 and beyond) After you have recovered from surgery (about 3-6 weeks later), you will begin receiving fulvestrant and abemaciclib. On Day 1 of each cycle, you will receive fulvestrant as an injection in your buttocks. On Days 1- 28 of each cycle, you will take abemaciclib tablets 2 times every day by mouth. You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. Length of Study You will receive the study drug(s) for as long as the study doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation in this study will be over after the 30-day follow-up phone call (described below). Study Visits On Day 1 of each cycle: You will have a physical exam. If the study doctor thinks it is needed, you will also have a pelvic exam. Blood (about 4 tablespoons) will be drawn for routine, tumor marker, and biomarker tests. Urine will be collected for routine tests. If you can become pregnant, part of this blood sample will be used for a pregnancy test. On Day 15 of Cycle 1, you will have a physical exam. On Day 1 of odd-numbered cycles after Cycle 1 (Cycles 3, 5, 7, and so on), you will have an MRI or CT scan. At your visit before the surgery, you will have a CT scan or MRI to check the status of the disease. During surgery, some of the tissue removed will be used to compare to tissue collected from you before you received chemotherapy so researchers can learn if the study drugs had any affect on the disease. This sample will be stored at MD Anderson for an unlimited amount of time for testing related to this study. End-of-Treatment Visit After the last dose of study drug(s): You will have a physical exam. Blood (about 1-2 tablespoons) will be drawn for routine, tumor marker, and biomarker tests. You will have an MRI or CT scan to check the status of the disease. Follow-Up About 30 days after the last dose of study drugs, the study staff will call you and ask how you are doing. This call should last about 5 minutes. ;
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