Clinical trial · Interventional
Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy
The Use of Intravenous Ferric Carboxymaltose (FCM) Without Erythropoiesis-stimulating Agents (ESA) in the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy With or Without Radiotherapy
NCT04246021CI-TRIAL-00055759completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferric carboxymaltose (FCM) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ferric carboxymaltose (ferrinject)
- description
- Patients will receive one or two doses of Ferric carboxymaltose (ferrinject), based on the body weight and Hb level. * Ferric carboxymaltose will be administered as a single infusion if the needed dose is 1000 mg as a short IV infusion * If the needed Ferric carboxymaltose dose is \> 1000 mg, an initial dose of 1000 mg will be given as a short IV infusion and the remaining dose will be given the week after in a similar fashion
- interventionNames
- Drug: Ferric carboxymaltose (FCM)
Primary outcomes (3)
- measure
- The Median Hb Change From Baseline to Week 12
- timeFrame
- up to 12 weeks
- description
- The median Hb change from baseline to week 12 per patient in the three groups, Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into the 3 groups: group I (absolute iron deficiency, n = 26) with sFr \< 30 ng/mL and TSAT \< 20%; group II (functional iron deficiency, n = 24) with sFr 30-800 ng/mL and TSAT \< 20%; and patients with TSAT ⩾ 20% were placed in group III as "others" (n = 34).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTAbdel-Razeq H, Saadeh SS, Malhis R, Yasser S, Abdulelah H, Eljaber R, Kleib A, Ismael R. Treatment of anemia in cancer patients undergoing chemotherapy with intravenous ferric carboxymaltose without erythropoiesis-stimulating agents. Ther Adv Med Oncol. 2020 Sep 9;12:1758835920953292. doi: 10.1177/1758835920953292. eCollection 2020. PMID 32952616