Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients

NCT03933813 | Terminated Phase 1 DMC

• 6 other identifiers: UW181062019-0022A532820SMPH/OB-GYN/GYN ONCOLOGYNCI-2019-02185Protocol Version 8/15/2019
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer; Anemia; Iron Deficiency Anemia

Keywords

ovarian cancer; anemia; iron deficiency; blood transfusion

Outcome Measures

Primary Outcomes (1)

• Rate of Peri-operative Blood Transfusion

  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 Outcomes (3)

• Rate of Iron Deficiency Anemia

  up to 21 days following surgery

• Rate of Resolution of Iron Deficiency Anemia After Intervention

  up to 21 days following surgery

• Incidence of Treatment Emergent Adverse Events (AEs)

  up to 21 days following surgery

Study Arms (1)

IV Iron Sucrose

EXPERIMENTAL

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

Other: Iron Sucrose

Interventions

Iron Sucrose OTHER

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

Also known as: Venofer

IV Iron Sucrose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Anemia; Anemia, Iron-Deficiency; Ovarian Neoplasms; Iron Deficiencies

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Lisa Barroilhet, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Unblinded, window of opportunity trial

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: July 29, 2019
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)