- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03933813
Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients
Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Carbone Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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Venofer (Iron Sucrose Injection USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Peri-operative Blood Transfusion
Time Frame: Within 72 hours of surgery, up to 5 weeks on study
|
Defined as a transfusion of Packed Red Blood Cells (PRBCs) within 72 hours of surgery, in iron deficient ovarian cancer patients who receive IV iron sucrose therapy prior to surgery compared to a historical controls (historically 77%).
The primary endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals.
Point estimates and exact 95% confidence intervals (CI) will be calculated.
|
Within 72 hours of surgery, up to 5 weeks on study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Iron Deficiency Anemia
Time Frame: up to 21 days following surgery
|
The rate of iron deficiency anemia in all ovarian cancers patients at the University of Wisconsin.
This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals.
In particular, point estimates and exact 95% confidence intervals (CI) will be calculated.
|
up to 21 days following surgery
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Rate of Resolution of Iron Deficiency Anemia After Intervention
Time Frame: up to 21 days following surgery
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Iron deficiency anemia is defined as ferritin > 30 ng/mL and iron saturation of < 50%. This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. In particular, point estimates and exact 95% confidence intervals (CI) will be calculated. |
up to 21 days following surgery
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Incidence of Treatment Emergent Adverse Events (AEs)
Time Frame: up to 21 days following surgery
|
Safety and Tolerability will be monitored by measuring adverse events data with date of onset (or worsening) on or after the start-date treatment with iron sucrose and end of study (post-operative visit (7 to 21 days following surgery). AEs are defined as mild, moderate and severe. This endpoint will be summarized with descriptive statistics and conducted using a Fisher's exact test and exact binomial confidence intervals. In particular, point estimates and exact 95% confidence intervals (CI) will be calculated. |
up to 21 days following surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa Barroilhet, MD, University of Wisconsin, Madison
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Hematologic Diseases
- Endocrine Gland Neoplasms
- Anemia, Hypochromic
- Iron Metabolism Disorders
- Anemia, Iron-Deficiency
- Ovarian Neoplasms
- Anemia
- Carcinoma, Ovarian Epithelial
- Hematinics
- Ferric Oxide, Saccharated
Other Study ID Numbers
- UW18106
- A532820 (Other Identifier: UW Madison)
- 2019-0022 (Other Identifier: Institutional Review Board)
- SMPH/OB-GYN/GYN ONCOLOGY (Other Identifier: UW Madison)
- NCI-2019-02185 (Registry Identifier: NCI Trial ID)
- Protocol Version 8/15/2019 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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