Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
16 Years
N/A
Both
Anemia, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
OBJECTIVES:
- Compare the efficacy of recombinant epoetin alfa or epoetin beta with vs without
parenteral iron in anemic, iron-replete patients with nonmyeloid malignancies.
OUTLINE: This is a randomized, controlled, open-label, prospective study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive recombinant erythropoietic stimulatory activity (ESA) therapy
comprising epoetin alfa or epoetin beta subcutaneously (SC) on day 1.
- Arm II: Patients receive ESA therapy as in arm I and parenteral iron (i.e., low
molecular weight iron dextran complex IV over 5-10 minutes or iron sucrose injection IV
over 10-30 minutes) on day 1.
In both arms, treatment repeats weekly for up to 10 weeks or until hemoglobin reaches 13
g/dL, whichever comes first.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of nonmyeloid malignancy
- No primary bone marrow malignancies except multiple myeloma, chronic lymphocytic
leukemia, or indolent non-Hodgkin lymphoma
- Candidate for erythropoietin stimulatory activity therapy for anemia due to cancer
and/or chemotherapy
- Baseline hemoglobin ≤ 10.5 g/dL
- Planning to receive ≥ 6 additional weeks of chemotherapy for the malignancy
- Demonstrates iron-replete status as defined by all of the following parameters:
- Percent saturation of transferrin ≥ 20%
- Serum ferritin 225-2,250 pmol/L
- Reticulocyte hemoglobin content > 31 pg
- Zinc protoporphyrin < 80 µg/dL
- No anemia of origin other than cancer or cancer chemotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No allergy or intolerance to recombinant epoetin alfa or epoetin beta
- No known sensitivity to iron sucrose injection or iron dextran complex
- No uncontrolled hypertension
- No active infection
- No active bleeding
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior iron sucrose injection or iron dextran complex therapy
- More than 6 months since prior and no concurrent transfusion
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Maximum hemoglobin achieved
Principal Investigator
Samir G Agrawal, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
St. Bartholomew's Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000549549
NCT ID:
NCT00482716
Start Date:
January 2007
Completion Date:
Related Keywords:
- Anemia
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- refractory multiple myeloma
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage I marginal zone lymphoma
- stage III marginal zone lymphoma
- stage IV marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage IV small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- refractory chronic lymphocytic leukemia
- anemia
- Anemia
- Neoplasms
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
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