Prospective, multicenter, randomized phase 3 trial of high dose IV iron in combination of erythrocytosis stimulating agents in chemotherapy induced anemia with functional iron deficiency
- Conditions
- Neoplasms
- Registration Number
- KCT0007849
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 312
? Patient who has signed a written consent
? Age = 19
? Histologically diagnosed advanced/metastatic solid cancer
? Patients who have received myelosuppressive chemotherapy for palliative purposes within 1 month of participating in the study and plan to proceed with chemotherapy while participating in this study
? Anemia with functional iron deficiency
1) Hemoglobin <10g/dL
2) functional iron deficiency: transferrin saturation <50% AND serum ferritin 30-800ng/mL
? ECOG performance status 0-2
? life expectancy = 24weeks
? Absolute iron deficiency (serum ferritin <30 ng/mL AND transferrin saturation <20%) or no iron deficiency (serum ferritin =800 ng/mL OR transferrin saturation =50%)
? If there is another cause of anemia other than chemotherapy-induced anemia (eg, vitamin B12 or folic acid deficiency, hemolytic anemia, myelodysplastic syndrome, etc.)
? Ongoing bleeding at the time of study registration
? Patients who require rapid blood transfusion at the time of study registration (eg, rapidly progressing anemia)
? Presence of bone marrow tumor invasion
? Receiving erythropoiesis stimulating agents within 3 weeks of study registration or have a history of oral or intravenous iron administration or blood transfusion within 2 weeks of study registration
? History of venous thromboembolism within 6 months or taking anticoagulants at the time of study registration
? Past or family history of hemochromatosis
? History of hypersensitivity to iron treatment or erythropoiesis stimulating agents
? Uncontrolled acute or chronic infection
? Renal dysfunction (serum creatinine =2.0 mg/dL, or glomerular filtration rate <30 mL/min/1.73 m2) or liver dysfuction (AST or ALT 3 times or more the upper limit of normal)
? Pregnant or lactating women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in Hb concentration from baseline to 12 weeks [end of treatment]
- Secondary Outcome Measures
Name Time Method ? Hemoglobin response: defined as an increase in Hb level of 2.0g/dL= from baseline value during 12-week study period ? Time to hemoglobin response ? Proportion of patients requiring RBC transfusion during 12-week study period ? Quality of life assessment by Functional Assessment of Cancer Therapy-Anemia (FACT-An)/health-related quality of life instrument with 8 items (HINT-8)/EQ-5D-5L ? Safety analysis ? Medical economics analysis ? Observation of gene expression patterns after combination therapy in cancer cell lines (by quantitative RT-PCR)