Clinical trial · Interventional
Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients
Evaluation and Treatment of Iron Deficiency in Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT03933813CI-TRIAL-00063017terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Iron Deficiency Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iron Sucrose | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IV Iron Sucrose
- description
- 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
- interventionNames
- Other: Iron Sucrose
Primary outcomes (1)
- measure
- Rate of Peri-operative Blood Transfusion
- timeFrame
- Within 72 hours of surgery, up to 5 weeks on study
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.