Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy

NCT05800600 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 22-1053HM-213
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of transfusions during neo-adjuvant period

  24 weeks

Study Arms (1)

Venofer treatment

EXPERIMENTAL

Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion

Drug: Venofer

Interventions

Venofer DRUG

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

Venofer treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Iberia Sosa, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Romasko

CONTACT

2678388380; ryan.romasko@fccc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 5, 2023
• Study Start: March 15, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)