Phase
Condition
Anemia
Treatment
Venofer
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients > 18 years
Patients undergoing neoadjuvant chemotherapy, including radiation and/orimmunotherapy, 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 HIPAAconsent document
Exclusion
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, ongoingactive infection, symptomatic new/exacerbated congestive heart failure, unstableangina pectoris, cardiac arrhythmia, or psychiatric illness/social situations thatwould 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 dueto 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)
Study Design
Study Description
Connect with a study center
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesActive - Recruiting
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