Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Hussein Cancer Center
• Collaborator: Hikma Pharmaceuticals LLC
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• Patient is an adult more than or equal 18 years old at the time of informed consent.

• Patient has pathologic diagnosis of solid tumor (breast cancer, colorectal, lung, sarcoma, head and neck, sarcoma, genitourinary or gynecological cancer).

• Patients who started chemotherapy (with or without radiotherapy) or planned to receive chemotherapy for at least 12 weeks.

• Patient has an Eastern Cooperative Oncology Group performance status between 0 and 2.

• Patient with Hb ≤11 g/dL.

• Patient has a Life expectancy at least 6 months.

• Adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum Creatinine level of less than 2 mg per deciliter.

• Patient is able to understand and provide informed consent to participate in the study.

Exclusion Criteria:

• Patient has Hb < 8.0 g/dL

• Patient presenting with hematologic malignancy including

• Prior gastric surgery.

• Patients on definitive radiotherapy alone.

• Patients with relevant history (within six weeks) or clinical evidence of hemolysis or active bleeding that could, in the investigator's judgment, be a potential cause for the anemia (no gross hematuria, hemoptysis, hematochezia or melena and negative stool for hemoccult)

• Presence of other nutritional anemia; deficiency of vitamin B12 less than 187 pg/ml and deficiency of Folate less than 3.1 ng/ml according to the local laboratory normal ranges

• Patient has Iron overload (Serum Ferritin more than 800 ng/ml or Transferrin saturation (TSAT) more than 40%)

• Patient is pregnant or lactating.

• Patient has a personal or family history of hemochromatosis.

• Patient has hypersensitivity to any form of IV iron.

• Patient has received red blood cells transfusion or used erythropoietin within 2 weeks of enrollment into the study.

• Patient has received any form of intravenous iron within the last 12 weeks

• Patient has received oral iron supplements within 1 month of enrollment to the study, except for multivitamin supplements containing less than 30 mg iron.