None listed
Conditions
Interventions
Drug : [ Active treatment arm: IV FCM]
Patients will receive an IV FCM (1,000 mg iron) infusion on the first day (visit 1) of chemotherapy. FCM (FerinjectTM
Vifor Pharma, Glattbrugg, Switzerland) will be diluted in 250 ml of sterile 0.9% normal saline by an aseptic technique and infused over 15 min under the supervision of a clinician.
• Patients with a
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 19 years at the time of study registration 2. Eastern Cooperative Oncology Group performance status = 2 3. Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma 4. Locally advanced unresectable or metastatic disease 5. Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma 6. Patients scheduled to receive palliative first-line fluoropyrimidine and platinum-based systemic therapy including targeted therapy or immunotherapy 7. Life expectancy =24 weeks 8. IDA a. Hb 8 to <11 g/dL b. Absolute ID (serum ferritin < 100 ng/mL) OR functional ID (TSAT* < 50% and serum ferritin 100-500 ng/mL) *TSAT = (serum iron level x 100)/ total iron-binding capacity (TIBC)
Exclusion criteria
Exclusion criteria: Inclusion Criteria 1. Age = 19 years at the time of study registration 2. Eastern Cooperative Oncology Group performance status = 2 3. Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma 4. Locally advanced unresectable or metastatic disease 5. Patients who have not been treated with palliative systemic antitumor agents for advanced or recurrent gastric or GEJ adenocarcinoma 6. Patients scheduled to receive palliative first-line fluoropyrimidine and platinum-based systemic therapy including targeted therapy or immunotherapy 7. Life expectancy =24 weeks 8. IDA a. Hb 8 to 500 ng/mL OR TSAT = 50%) 4. Anemia attributable to factors other than cancer or chemotherapy (e.g., vitamin B12 and/or serum folate deficiency; hemolysis; or myelodysplastic syndromes) 5. Ongoing bleeding or overt gross active bleeding (e.g., hematemesis, melena, or hematochezia) 6. Neoplastic bone marrow infiltration 7. History of ESA, IV or oral iron therapy, and/or RBC transfusion 4 weeks prior to randomization 8. Iron overload or disturbances in utilization of iron (e.g., personal or family history of hemochromatosis and hemosiderosis) 9. Known hypersensitivity to any of the required study products or known serious hypersensitivity to other parenteral iron products 10. Known severe allergies including drug allergies, history of severe asthma, eczema or other atopic allergies, and in subjects with immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis) 11. Decreased renal function including renal dialysis (previous, current or planned within the next 6 months,) or serum creatinine levels = 2.0 mg/dL, or estimated glomerular filtration rate < 30 mL/min/1.73 m2 12. Chronic liver disease (including active hepatitis) and/or aspartate transaminase (AST) or alanine transaminase (ALT) = 3 times the upper limit of the normal range 13. Active acute or chronic infections (assessed by clinical judgment) 14. Other significant medical condition(s) in the opinion of the investigator with an anticipated need for major surgery during the study, or any other kind of disorder that may be associated with increased risk to the subject or may interfere with study assessments, outcomes (e.g., uncontrolled hypertension, active cardiac disease, thromboembolic disease, or uncontrolled diabetes mellitus, neurological or psychiatric disorders) 15. Pregnancy (e.g., positive human chorionic gonadotropin test) or breast-feeding. If the subject is of childbearing potential and does, not use adequate contraceptive precautions. The subject must agree to use adequate contraception during the study and for 1 month after the last dose of study treatment. A highly effective method of birth control must be used.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum change of Hb concentration from baseline to 12 weeks (or first RBC transfusion and/or ESA, or study withdrawl, or death, whichever will be first) without RBC transfusion and/or ESA | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Hb concentration from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks;Change in serum iron, ferritin, TIBC, and TSAT from baseline to 3, 6, 9, 12, 24, 36, and 48 weeks;Tumor response as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1);progression-free survival [PFS];overall survival [OS];Change in QOL score from baseline to 6, 12, 24, 36 and 48 weeks ;safety | — |
Countries
Korea, Republic of
Contacts
Public ContactMin-Hee Ryu
Asan Medical Center
Outcome results
None listed