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

Lymphoma Clinical Trial

Official title:

Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00482716
• Other study ID #: CDR0000549549
• Secondary ID: BARTS-06/Q0605/9
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 4, 2007
• Last updated: January 9, 2014
• Start date: January 2007

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Biological:
• epoetin alfa

• epoetin beta

Dietary Supplement:
• iron dextran complex

• iron sucrose injection

Locations

Country	Name	City	State
United Kingdom	Saint Bartholomew's Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
St. Bartholomew's Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum hemoglobin achieved
Secondary	Time to zenith hemoglobin or achievement of hemoglobin level = 13 g/dL