Clinical trial NCT04246021: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Cancer
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
Collaborators: name: Hikma Pharmaceuticals LLC
First posted: 2020-01-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Median Hb Change From Baseline to Week 12
timeFrame: up to 12 weeks
measure: Percentage of Patients With Hb Increment of at Least 1.0 gm/dL.
timeFrame: up to 12 weeks
measure: Percentage of Patients Achieving Correction of Anemia (Hb >11.0 gm/dL)
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Response Rate in Relation to Baseline Iron Deficiency Status
timeFrame: up to 12 weeks
measure: Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References:
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.