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

NCT ID: NCT00482716

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

Brief Summary

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.

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.

Conditions

Anemia; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

epoetin alfa

Intervention Type: BIOLOGICAL

epoetin beta

Intervention Type: BIOLOGICAL

iron dextran complex

Intervention Type: DIETARY_SUPPLEMENT

iron sucrose injection

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Bartholomew's Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Samir G Agrawal, MD, PhD

Role: STUDY_CHAIR

St. Bartholomew's Hospital

Locations

Saint Bartholomew's Hospital

London, England, United Kingdom

Countries

United Kingdom

Other Identifiers

BARTS-06/Q0605/93

Identifier Type: -

Identifier Source: secondary_id

ISRCTN11830961

Identifier Type: -

Identifier Source: secondary_id

EU-20731

Identifier Type: -

Identifier Source: secondary_id

CDR0000549549

Identifier Type: -

Identifier Source: org_study_id