The Efficacy of Intravenous Iron for the Treatment of Anemia in Cancer Patients

Samsung Medical Center

Status and phase

Unknown

Phase 2

Conditions

Anemia

Cancer

Treatments

Drug: Ferinject®

Study type

Interventional

Funder types

Other

Identifiers

2015-01-011-001

Details and patient eligibility

About

Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects who diagnosed with solid cancer or lymphoma
Subjects who are under anti-cancer therapy at enrollment or has finished anti-cancer therapy within 2 months before enrollment
- anticancer therapy: "chemotherapy", and/or "chemotherapy + radiotherapy", and/or "target agent"
Subjects whose Hb level is 8.0-10.5g/dL, or who experienced a drop of Hb by 2g/dL or more during anti-cancer treatment

Exclusion criteria

Subjects who received iron (oral or iv), ESA, dialysis within 4 weeks before enrollment
Subjects with uncontrolled infection
Subjects with ongoing bleeding
Deteriorated organ function
poor performance state (ECOG 3-4)
Subjects whose disease involves bone marrow
Ferritin > 800 ng/ml and Transferrin saturation(TSAT) ≥ 50%