Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
NCT ID: NCT00255749
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
89 participants
INTERVENTIONAL
2005-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
early intervention epoietin alfa
Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
epoetin alfa
standard intervention epoietin alfa
Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
epoetin alfa
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
epoetin alfa
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John A. Glaspy, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCLA-0504038
Identifier Type: -
Identifier Source: secondary_id
ORTHO-PR04-27-018
Identifier Type: -
Identifier Source: secondary_id
CDR0000449950
Identifier Type: -
Identifier Source: org_study_id