This trial is active, not recruiting.

Conditions anemia, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, unspecified adult solid tumor, protocol specific
Treatments epoetin alfa, epoetin beta, iron dextran complex, iron sucrose injection
Phase phase 3
Sponsor St. Bartholomew's Hospital
Start date January 2007
Trial size 80 participants
Trial identifier NCT00482716, BARTS-06/Q0605/93, CDR0000549549, EU-20731, ISRCTN11830961


RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether epoetin alfa or epoetin beta are more effective when given with or without iron infusion in treating anemia in patients with cancer.

PURPOSE: This randomized phase III trial is studying epoetin alfa or epoetin beta to compare how well they work with or without iron infusion in treating anemia in patients with cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Masking open label
Primary purpose supportive care

Primary Outcomes

Maximum hemoglobin achieved
time frame:

Secondary Outcomes

Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL
time frame:

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).