Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients

NCT ID: NCT03933813

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2021-11-22

Brief 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.

Detailed 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.

Conditions

Epithelial Ovarian Cancer; Anemia; Iron Deficiency Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

IV Iron Sucrose

Four intravenous iron sucrose infusions prior to debulking surgery administered as four 200mg infusions, given no less than 7 days apart over a 30 day +/- 7 day period

Group Type: EXPERIMENTAL

Iron Sucrose

Intervention Type: OTHER

Venofer (Iron Sucrose Injection USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.

Interventions

Iron Sucrose

Venofer (Iron Sucrose Injection USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.

Intervention Type: OTHER

Other Intervention Names

Venofer

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent.
• Has a diagnosis of true or functional iron deficiency without anemia within 30 days of treatment 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 saturation of <50%)
• Has a clinical diagnosis of suspected epithelial ovarian cancer based on imaging studies, exam findings and laboratory values
• Participants must be planning to receive neoadjuvant chemotherapy for their cancer diagnosis (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 test within 7 days prior to administration of first dose of IV iron sucrose. WOCBP is defined 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 control during study participation. Effective birth control is defined as any FDA approved contraceptive method

Exclusion Criteria

• Currently taken any form of oral or intravenous iron therapy. Patients must have discontinued 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 this study
• Any medical condition which could compromise participation in the study according to the investigator's assessment
• Female patient who is pregnant or breast-feeding
• Patients unwilling or unable to comply with the protocol or unable to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Barroilhet, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Related Links

https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

2019-0022

Identifier Type: OTHER

Identifier Source: secondary_id

A532820

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/OB-GYN/GYN ONCOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2019-02185

Identifier Type: REGISTRY

Identifier Source: secondary_id

Protocol Version 8/15/2019

Identifier Type: OTHER

Identifier Source: secondary_id

UW18106

Identifier Type: -

Identifier Source: org_study_id