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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- The Median Hb Change From Baseline to Week 12
研究概览
简要总结
This study is a nonrandomized, single arm, open-label study stratified by iron-deficiency status.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Ferric carboxymaltose (FCM) (Drug)
结局指标
主要结局
The Median Hb Change From Baseline to Week 12
时间窗: up to 12 weeks
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.
时间窗: up to 12 weeks
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)
时间窗: up to 12 weeks
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).
次要结局
- Response Rate in Relation to Baseline Iron Deficiency Status(up to 12 weeks)
- Percentage of Patients Who Will Require Blood Transfusion or ESA Treatment(up to 12 weeks)
研究者
Hikmat Abdel-Razeq
Chief Medical Officer and Deputy Director General King Hussein Cancer Center
King Hussein Cancer Center