Clinical trial NCT00482716: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Maximum hemoglobin achieved
Secondary outcomes:
measure: Time to zenith hemoglobin or achievement of hemoglobin level ≥ 13 g/dL
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Saint Bartholomew's Hospital
state: England
Study officials:
affiliation: St. Bartholomew's Hospital
name: Samir G Agrawal, MD, PhD
role: STUDY_CHAIR
References: