This phase II trial evaluates the effectiveness of Venofer for improving chemotherapy-induced anemia and reducing need for blood transfusions in patients undergoing neoadjuvant chemotherapy for breast, thoracic, gastrointestinal, or genitourinary cancer. Anemia is a frequent complication in patients with solid tumor malignancies during cancer treatment. Chemotherapy-induced anemia (CIA) leads to delays in cancer treatments, poor quality of life, and has been identified as a predictor of shorter survival time, hence the importance for prompt diagnosis and intervention. Patients who undergo chemotherapy before surgery (neoadjuvant) are particularly at risk for CIA and anemia prior to surgery increases risk of complications. Venofer replaces iron in the blood and promotes red blood cell production. It has been approved for iron deficiency-related anemia, but is not approved for anemia in patients undergoing chemotherapy. Giving Venofer infusions during the neoadjuvant period may reduce the need for transfusions required to support patients during their chemotherapy and improve hemoglobin levels in anticipation of their planned surgery. The information from this study may help doctors learn more about Venofer as a supportive therapy for chemotherapy-induced anemia treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT05800600.
Locations matching your search criteria
United States
Pennsylvania
East Norriton
Fox Chase Cancer Center - East Norriton Hospital Outpatient CenterStatus: Active
Contact: Iberia Romina Sosa
Phone: 215-728-4300
Philadelphia
Temple University HospitalStatus: Active
Contact: Iberia Romina Sosa
Phone: 215-728-4300
Fox Chase Cancer CenterStatus: Active
Contact: Iberia Romina Sosa
Phone: 215-728-2684
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia by improving the hemoglobin of patients undergoing neoadjuvant chemotherapy.
SECONDARY OBJECTIVE:
I. To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy.
EXPLORATORY OBJECTIVES:
I. To identify which cancer subtypes are most likely to benefit from iron infusion interventions.
II. To identify ferritin levels that predict patients who are more likely to benefit from this intervention with iron infusions.
III. To determine whether hepcidin levels correlate with iron studies and whether iron infusions affect iron homeostasis, as determined by hepcidin levels.
OUTLINE:
Patients receive iron sucrose (Venofer) intravenously (IV) over 15 minutes to 1 hour for 5 doses or ferric carboxymaltose (Injectafer) IV for 2 doses or ferric derisomaltose (Monoferric) IV for 1 dose during neoadjuvant chemotherapy (9-24 weeks) on study. Patients may receive Venofer IV over 15 minutes to 1 hour for 2 doses following neoadjuvant chemotherapy during the pre-surgical period (6-8 weeks) as clinically indicated. Patients also undergo collection of blood samples at screening and on study.
Patients are followed up after surgery.
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorIberia Romina Sosa
