Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients (NCT03933813) | Clinical Trial Compass
TerminatedPhase 1/2
Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients
Stopped: slow accrual
United States9 participantsStarted 2019-07-29
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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, ly…
What they're measuring
1
Rate of Peri-operative Blood Transfusion
Timeframe: Within 72 hours of surgery, up to 5 weeks on study