Iron-RANC: Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Venofer treatment Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion |
Drug: Venofer
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
|
Outcome Measures
Primary Outcome Measures
- Mean change from baseline to highest Hgb value [6 weeks]
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.
Secondary Outcome Measures
- Number of transfusions during neo-adjuvant period [24 weeks]
To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy.
Eligibility Criteria
Criteria
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.
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Anemia defined as Hgb <10.5 g/dL during chemotherapy.
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Iron storage levels of ferritin <500 ng/mL and iron saturation <35%
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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
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Prior parenteral iron infusion in the past 4 weeks
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The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD
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Concurrent systemic infection at the time of enrollment.
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Known hypersensitivity to Iron sucrose
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Pregnant or breast feeding. Refer to section 4.4 for further detail.
-
Anemia from another established etiology (i.e MDS, Myeloma)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
Sponsors and Collaborators
- Fox Chase Cancer Center
Investigators
- Principal Investigator: Iberia Sosa, MD, Fox Chase Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-1053
- HM-213