This phase II trial studies how well iron sucrose works in treating iron deficiency in patients with ovarian cancer who are receiving chemotherapy before surgery. Patients with ovarian cancer often have iron deficiency anemia and chemotherapy can make the anemia worse. Iron sucrose may reduce the need for blood transfusions by treating iron deficiency before it develops into anemia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03933813.
PRIMARY OBJECTIVES:
I. To determine the rate of peri-operative blood transfusion, defined as a transfusion of packed red blood cells (PRBCs) within 72 hours of surgery, in iron deficient, non-anemic, ovarian cancer patients who receive intravenous (IV) iron sucrose therapy prior to surgery compared to historical controls.
SECONDARY OBJECTIVES:
I. To determine the rate iron deficiency without anemia and functional iron deficiency in ovarian cancer patients at our institution.
II. To determine the rates of resolution of iron deficiency after subjects receive IV iron sucrose therapy.
III. To determine the safety and tolerability of IV iron sucrose therapy in this patient population.
OUTLINE:
Patients receive iron sucrose IV over 15-30 minutes on days 1 and 10. Treatment repeats every 21-28 days for up to 2 cycles in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up between 7-21 days after surgery.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorLisa Marie Barroilhet
