Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients

Phase

1/2

Condition

Anemia

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT03933813

UW18106

2019-0022

SMPH/OB-GYN/GYN ONCOLOGY

Protocol Version 8/15/2019

NCI-2019-02185

A532820

Ages > 18
Female

Study Summary

This study tests the hypothesis that IV iron sucrose infusions given to iron deficient ovarian cancer patients prior to debulking surgery can improve pre-operative iron stores and decrease transfusion of packed red blood cells in the peri-operative period. 21 participants at least 18 years of age with epithelial ovarian cancer of any stage requiring neoadjuvant chemotherapy and surgery will be enrolled. Participants will be on study for a period of up to 3 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Provide written informed consent.
Has a diagnosis of true or functional iron deficiency without anemia within 30 days oftreatment on this protocol
Iron deficiency without anemia (normal Hgb >/= 11.6 g/dL but ferritin < 30 ng/mL)
Functional iron deficiency without anemia (ferritin >30 ng/ml and iron saturationof <50%)
Has a clinical diagnosis of suspected epithelial ovarian cancer based on imagingstudies, exam findings and laboratory values
Participants must be planning to receive neoadjuvant chemotherapy for their cancerdiagnosis (NACT is defined as chemotherapy prior to debulking surgery)
Participants must be planning to undergo surgery for their cancer diagnosis
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy testwithin 7 days prior to administration of first dose of IV iron sucrose. WOCBP isdefined as patients who retain their reproductive structures and are not menopausal (defined as > age 50 with no menses for at least 1 year)
Participants of reproductive potential must agree to use effective birth controlduring study participation. Effective birth control is defined as any FDA approvedcontraceptive method

Exclusion

Exclusion Criteria:

Currently taken any form of oral or intravenous iron therapy. Patients must havediscontinued iron therapy > 30 days from study entry
Current untreated or unstable heart disease
History of iron induced hypersensitivity or allergy
History of leukemia, lymphoma, or other myelodysplastic disorders
Prior diagnosis of hemochromatosis or hemoglobinopathy (e.g. thalassemia)
Any subject with immediate requirement for radiotherapy
Concomitant enrollment in another clinical trial interfering with endpoints on thisstudy
Any medical condition which could compromise participation in the study according tothe investigator's assessment
Female patient who is pregnant or breast-feeding
Patients unwilling or unable to comply with the protocol or unable to give informedconsent

Study Design

July 29, 2019

November 22, 2021

Study Description

Iron deficiency and anemia are common in cancer patients. Data from the University of Wisconsin (UW) suggest that more than 50% of ovarian cancer patients undergo blood transfusion during their cancer treatments. Transfusion rates are particularly high in patients who receive neoadjuvant chemotherapy (NACT), despite multiple opportunities to diagnose and treat anemia prior to surgery. Blood transfusions have been associated with worse survival in ovarian cancer patients. Seventy-seven percent of ovarian cancer patients who receive NACT at the UW are anemic prior to surgery, and the same percentage receive a perioperative blood transfusion, defined as a blood transfusion within 72 hours of surgery. Iron deficiency without anemia is also common in cancer patients, though little has been published regarding how frequently it occurs in ovarian cancer patients. Functional iron deficiency, a lack of iron incorporation into erythroid precursors despite adequate iron stores, is also common in cancer patients. Study investigators hypothesize that IV iron sucrose infusions given to iron deficient ovarian cancer patients prior to debulking surgery can improve pre-operative iron stores and decrease transfusion of packed red blood cells in the peri-operative period.

Eligible participants will have a new epithelial ovarian cancer diagnosis, with planned neoadjuvant chemotherapy and interval debulking surgery. The study cohort will consist of participants with iron deficiency without anemia (defined below) prior to starting chemotherapy. Iron deficient participants with anemia are already offered iron sucrose infusions as part of their standard of care treatment.

The study group will include participants with planned neoadjuvant chemotherapy and debulking surgery with a normal Hgb within 30 days of study enrollment. Iron studies including ferritin, transferrin, total iron binding capacity (TIBC), reticulocyte count and serum iron, will be performed on these participants for research purposes only. Consent will be obtained prior to drawing research-related iron studies. The majority of participants will have Hgb levels available in their records from the last 30 days, either from the UW, or from a referring institution. If this is not the case, pre-chemotherapy lab studies will be obtained the day of their visit, which would routinely include a Hgb level.

Participants will sign a consent to receive four IV iron sucrose transfusions, prior to their debulking surgery, and be followed for prospective data collection. Consent will be signed for the infusion and for prospective data collection related to future laboratory studies and rates of transfusion of blood products. Participants with a normal Hgb and normal iron studies will participate in the prospective data collection portion of this study only. Prospective data collection will continue until subjects have completed first-line chemotherapy.

Subjects will be enrolled until 21 evaluable participants have been enrolled. Evaluable participants will have true or functional iron deficiency without anemia and have received at least one IV iron sucrose infusion.

Iron studies will be repeated 21 days (+/- 7 days) after last infusion in participants who receive IV iron sucrose. Participants with persistent iron deficiency will be referred to hematology.

Connect with a study center

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United States
Site Not Available

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