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

Primary Purpose

Anemia, Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ferric carboxymaltose (FCM)
Sponsored by
King Hussein Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ferric carboxymaltose (ferrinject)

    Arm 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

    Outcomes

    Primary Outcome Measures

    The Median Hb Change From Baseline to Week 12
    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).
    Percentage of Patients With Hb Increment of at Least 1.0 gm/dL.
    Percentage of patients with Hb increment of at least 1.0 gm/dL during their participation (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).
    Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL)
    Percentage of patients achieving correction of anemia (Hb >11.0 gm/dL) during their participation (from baseline to week 12 per patient) in the three groups. A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 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).

    Secondary Outcome Measures

    Response Rate in Relation to Baseline Iron Deficiency Status
    Response rate in relation to baseline iron deficiency status; Patients were considered responders if they showed a minimum of 1.0 gm/dL increment in Hb level during their participation (from baseline to week 12 per patient) Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 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).
    Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment
    Percentage of patients who received red blood cells (RBCs) transfusion or used erythropoietin during their participation (from baseline to week 12 per patient) among the 84 recruited adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL

    Full Information

    First Posted
    January 26, 2020
    Last Updated
    December 8, 2021
    Sponsor
    King Hussein Cancer Center
    Collaborators
    Hikma Pharmaceuticals LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04246021
    Brief Title
    Use of Intravenous Ferric Carboxymaltose in Treatment of Anemia in Cancer Patients Undergoing Chemotherapy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2016 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Hussein Cancer Center
    Collaborators
    Hikma Pharmaceuticals LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
    Detailed Description
    The study aims to investigate the effect of FCM (without ESAs) on anemic cancer patients undergoing chemotherapy (with or without radiotherapy); stratified by status of iron deficiency (i.e. non-iron deficient vs. iron deficient patients ). The study will also try to find out whether serum level of Hepcidin and C reactive protein can correlate with response Patients will receive one or two doses of FCM, based on the body weight and Hb level. Patients will be followed-up for a total of twelve weeks. The study is divided into a screening, treatment and follow-up phases and is expected to be completed in 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anemia, Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ferric carboxymaltose (ferrinject)
    Arm Type
    Experimental
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Ferric carboxymaltose (FCM)
    Other Intervention Name(s)
    Ferinject
    Intervention Description
    intravenous iron formulation
    Primary Outcome Measure Information:
    Title
    The Median Hb Change From Baseline to Week 12
    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).
    Time Frame
    up to 12 weeks
    Title
    Percentage of Patients With Hb Increment of at Least 1.0 gm/dL.
    Description
    Percentage of patients with Hb increment of at least 1.0 gm/dL during their participation (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).
    Time Frame
    up to 12 weeks
    Title
    Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL)
    Description
    Percentage of patients achieving correction of anemia (Hb >11.0 gm/dL) during their participation (from baseline to week 12 per patient) in the three groups. A total of 84 adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL were recruited. Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 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).
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Response Rate in Relation to Baseline Iron Deficiency Status
    Description
    Response rate in relation to baseline iron deficiency status; Patients were considered responders if they showed a minimum of 1.0 gm/dL increment in Hb level during their participation (from baseline to week 12 per patient) Based on serum ferritin (sFr) and transferrin saturation(TSAT), patients were divided into 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).
    Time Frame
    up to 12 weeks
    Title
    Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment
    Description
    Percentage of patients who received red blood cells (RBCs) transfusion or used erythropoietin during their participation (from baseline to week 12 per patient) among the 84 recruited adult cancer patients on active chemotherapy with hemoglobin (Hb) level ⩽11.0 g/dL
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32952616
    Citation
    Abdel-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.
    Results Reference
    result

    Learn more about this trial

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

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