Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.

Detailed Description
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This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.

Official Title
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Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

Conditions
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Anemia

Intervention / Treatment
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* Drug: Venofer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients > 18 years Patients undergoing neoadjuvant chemotherapy, including radiation and/or immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies. Anemia defined as Hgb <10.5 g/dL during chemotherapy. Iron storage levels of ferritin <500 ng/mL and iron saturation <35% Ability to understand and willingness to sign a written informed consent and HIPAA consent document Exclusion Criteria: Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb < 11.0 g/dL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new/exacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Prior parenteral iron infusion in the past 4 weeks The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD Concurrent systemic infection at the time of enrollment. Known hypersensitivity to Iron sucrose Pregnant or breast feeding. Refer to section 4.4 for further detail. Anemia from another established etiology (i.e MDS, Myeloma)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Venofer treatment<br>Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion | Drug: Venofer<br>* Intravenous iron will be administered as five doses of 200 mg of iron sucrose (Venofer, American Regent, Shirley, NJ) in 100 ml normal saline over a duration of 15 minutes to 1 hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to highest Hgb value | To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia by improving the hemoglobin of patients undergoing neoadjuvant chemotherapy. Mean change from baseline to highest Hgb value observed six weeks after last iron infusion, before day of surgery. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of transfusions during neo-adjuvant period | To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy. | 24 weeks |