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

NCT ID: NCT04246021

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2017-12-31

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.

Conditions

Anemia; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric carboxymaltose (ferrinject)

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

Group Type: EXPERIMENTAL

Ferric carboxymaltose (FCM)

Intervention Type: DRUG

intravenous iron formulation

Interventions

Ferric carboxymaltose (FCM)

intravenous iron formulation

Intervention Type: DRUG

Other Intervention Names

Ferinject

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hikma Pharmaceuticals LLC

INDUSTRY

Sponsor Role: collaborator

King Hussein Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Hikmat Abdel-Razeq

Chief Medical Officer and Deputy Director General King Hussein Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 32952616 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PRT-INM-0615/09

Identifier Type: -

Identifier Source: org_study_id