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

Primary Purpose

Anemia, Leukemia, Lymphoma

Status

Unknown status

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

epoetin alfa

epoetin beta

iron dextran complex

iron sucrose injection

About this trial

This is an interventional supportive care trial for Anemia focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Saint Bartholomew's Hospital

Outcomes

Primary Outcome Measures

Maximum hemoglobin achieved

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00482716

First Posted

June 4, 2007

Last Updated

January 9, 2014

Sponsor

St. Bartholomew's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00482716

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

St. Bartholomew's Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

epoetin alfa

Intervention Type

Biological

Intervention Name(s)

epoetin beta

Intervention Type

Dietary Supplement

Intervention Name(s)

iron dextran complex

Intervention Type

Dietary Supplement

Intervention Name(s)

iron sucrose injection

Primary Outcome Measure Information:

Title

Maximum hemoglobin achieved

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samir G Agrawal, MD, PhD

Organizational Affiliation

St. Bartholomew's Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Saint Bartholomew's Hospital

City

London

State/Province

England

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

12. IPD Sharing Statement

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

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