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Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

Primary Purpose

Anemia, Leukemia, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia focused on measuring adult acute lymphoblastic leukemia in remission, progressive hairy cell leukemia, initial treatment, stage 0 chronic lymphocytic leukemia, anemia, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult T-cell leukemia/lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III mycosis fungoides/Sezary syndrome, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV mycosis fungoides/Sezary syndrome, stage IV small lymphocytic lymphoma, Waldenström macroglobulinemia, contiguous stage II adult Burkitt lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult lymphoblastic lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, post-transplant lymphoproliferative disorder, stage I adult Burkitt lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult Hodgkin lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult T-cell leukemia/lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage I mantle cell lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage II adult Hodgkin lymphoma, stage II adult T-cell leukemia/lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, refractory hairy cell leukemia, prolymphocytic leukemia, unspecified adult solid tumor, protocol specific, T-cell large granular lymphocyte leukemia

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed nonmyeloid cancer No history of myelodysplasia Baseline hemoglobin 11-12 g/dL No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding) Receiving chemotherapy that meets the following criteria: Administered weekly OR every 3 weeks Must begin chemotherapy on or before the first day of study treatment No known, untreated CNS metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent) Iron transferrin saturation > 20% No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency) Hepatic Bilirubin < 2.0 mg/dL SGPT ≤ 3 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL No significant, uncontrolled genitourinary disease or dysfunction Cardiovascular No uncontrolled cardiac arrhythmia in the past 6 months No uncontrolled hypertension No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events Superficial thromboses allowed No other significant, uncontrolled cardiovascular disease or dysfunction Pulmonary No significant, uncontrolled pulmonary disease or dysfunction No pulmonary emboli Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No infection requiring hospitalization or antibiotics in the past 14 days No known hypersensitivity to mammalian cell-derived products or to human albumin No new onset (in the past 3 months) poorly controlled seizures No other active malignancy except basal cell carcinoma or carcinoma in situ Not an employee of the investigator or study center or family members of the employee or the investigator No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin) More than 4 weeks since prior packed red blood cell transfusion No concurrent stem cell harvest of bone marrow No concurrent interleukin-11 No other concurrent erythropoietic agent Chemotherapy See Disease Characteristics No concurrent high-dose chemotherapy with stem cell transplantation Radiotherapy No concurrent nonpalliative radiotherapy Surgery More than 2 weeks since prior major surgery Other At least 1 month since prior investigational agents or devices No concurrent high-dose IV iron supplementation

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

early intervention epoietin alfa

standard intervention epoietin alfa

Arm Description

Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.

Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Outcomes

Primary Outcome Measures

Efficacy
Safety

Secondary Outcome Measures

Quality of life

Full Information

First Posted
November 18, 2005
Last Updated
October 3, 2012
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00255749
Brief Title
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
Official Title
Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. PURPOSE: This randomized phase II trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.
Detailed Description
OBJECTIVES: Primary Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer. Determine the safety of this drug in these patients. Secondary Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses. Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL. Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment. After completion of study treatment, patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Leukemia, Lymphoma, Lymphoproliferative Disorder, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
adult acute lymphoblastic leukemia in remission, progressive hairy cell leukemia, initial treatment, stage 0 chronic lymphocytic leukemia, anemia, extramedullary plasmacytoma, isolated plasmacytoma of bone, refractory multiple myeloma, monoclonal gammopathy of undetermined significance, primary systemic amyloidosis, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III adult T-cell leukemia/lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III mycosis fungoides/Sezary syndrome, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV mycosis fungoides/Sezary syndrome, stage IV small lymphocytic lymphoma, Waldenström macroglobulinemia, contiguous stage II adult Burkitt lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult diffuse mixed cell lymphoma, contiguous stage II adult diffuse small cleaved cell lymphoma, contiguous stage II adult immunoblastic large cell lymphoma, contiguous stage II adult lymphoblastic lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II marginal zone lymphoma, noncontiguous stage II small lymphocytic lymphoma, post-transplant lymphoproliferative disorder, stage I adult Burkitt lymphoma, stage I adult diffuse large cell lymphoma, stage I adult diffuse mixed cell lymphoma, stage I adult diffuse small cleaved cell lymphoma, stage I adult Hodgkin lymphoma, stage I adult immunoblastic large cell lymphoma, stage I adult lymphoblastic lymphoma, stage I adult T-cell leukemia/lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage I mantle cell lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage II adult Hodgkin lymphoma, stage II adult T-cell leukemia/lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, recurrent adult acute lymphoblastic leukemia, refractory chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, refractory hairy cell leukemia, prolymphocytic leukemia, unspecified adult solid tumor, protocol specific, T-cell large granular lymphocyte leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early intervention epoietin alfa
Arm Type
Experimental
Arm Description
Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
Arm Title
standard intervention epoietin alfa
Arm Type
Other
Arm Description
Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
Intervention Type
Biological
Intervention Name(s)
epoetin alfa
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
7 weeks
Title
Safety
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed nonmyeloid cancer No history of myelodysplasia Baseline hemoglobin 11-12 g/dL No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding) Receiving chemotherapy that meets the following criteria: Administered weekly OR every 3 weeks Must begin chemotherapy on or before the first day of study treatment No known, untreated CNS metastases PATIENT CHARACTERISTICS: Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic See Disease Characteristics Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 (transfusion independent) Iron transferrin saturation > 20% No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency) Hepatic Bilirubin < 2.0 mg/dL SGPT ≤ 3 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL No significant, uncontrolled genitourinary disease or dysfunction Cardiovascular No uncontrolled cardiac arrhythmia in the past 6 months No uncontrolled hypertension No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events Superficial thromboses allowed No other significant, uncontrolled cardiovascular disease or dysfunction Pulmonary No significant, uncontrolled pulmonary disease or dysfunction No pulmonary emboli Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No infection requiring hospitalization or antibiotics in the past 14 days No known hypersensitivity to mammalian cell-derived products or to human albumin No new onset (in the past 3 months) poorly controlled seizures No other active malignancy except basal cell carcinoma or carcinoma in situ Not an employee of the investigator or study center or family members of the employee or the investigator No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin) More than 4 weeks since prior packed red blood cell transfusion No concurrent stem cell harvest of bone marrow No concurrent interleukin-11 No other concurrent erythropoietic agent Chemotherapy See Disease Characteristics No concurrent high-dose chemotherapy with stem cell transplantation Radiotherapy No concurrent nonpalliative radiotherapy Surgery More than 2 weeks since prior major surgery Other At least 1 month since prior investigational agents or devices No concurrent high-dose IV iron supplementation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Glaspy, MD, MPH
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19170225
Citation
Glaspy JA, Charu V, Luo D, Moyo V, Kamin M, Wilhelm FE. Initiation of epoetin-alpha therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy: an open-label, multicenter study with randomized and nonrandomized treatment arms. Cancer. 2009 Mar 1;115(5):1121-31. doi: 10.1002/cncr.24127.
Results Reference
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Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

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