Epoetin Alfa or Epoetin Beta With or Without Iron Infusion in Treating Anemia in Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00482716
First received: June 4, 2007
Last updated: January 9, 2014
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Anemia
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Unspecified Adult Solid Tumor, Protocol Specific
Biological: epoetin alfa
Biological: epoetin beta
Dietary Supplement: iron dextran complex
Dietary Supplement: iron sucrose injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum hemoglobin achieved

Secondary Outcome Measures:
  • Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL

Estimated Enrollment: 80
Study Start Date: January 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482716

Locations
United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Sponsors and Collaborators
St. Bartholomew's Hospital
Investigators
Study Chair: Samir G Agrawal, MD, PhD St. Bartholomew's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00482716     History of Changes
Other Study ID Numbers: CDR0000549549, BARTS-06/Q0605/93, ISRCTN11830961, EU-20731
Study First Received: June 4, 2007
Last Updated: January 9, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Anemia
Neoplasms
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Hematologic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Dextrans
Epoetin alfa
Iron-Dextran Complex
Ferric oxide, saccharated
Iron
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes

ClinicalTrials.gov processed this record on August 20, 2014