Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy
NCT ID: NCT00416624
Last Updated: 2017-02-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
239 participants
INTERVENTIONAL
2007-05-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This randomized clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With a Non-Myeloid Malignancy
NCT00117624
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy
NCT00270166
Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer
NCT00070382
Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer
NCT00661999
A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy
NCT00118638
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with chemotherapy-associated anemia who achieve a weekly and overall hematopoietic response.
Secondary
* Compare the effect of these regimens on the mean hemoglobin increment measured weekly from baseline to 15 weeks in patients with a baseline hemoglobin of less than or equal to 10.5 g/dL.
* Compare the time required to achieve hemoglobin levels within the goal range 11.0-12.0 g/dL in patients treated with these regimens.
* Compare the effect of these regimens on the proportion of patients requiring red blood cell transfusions and on the number of transfusions required.
* Compare the weekly change in hemoglobin in patients treated with these regimens.
* Compare the need for dose reduction in patients treated with these regimens.
* Compare the adverse event profiles of these regimens in these patients.
* Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, unblinded, pilot study. Patients are stratified according to severity of anemia (mild \[hemoglobin ≥ 9.5 g/dL\] vs severe \[hemoglobin \< 9.5 g/dL\]), platinum-containing regimen (yes vs no), and tumor type (nonmyeloid hematologic malignancy vs solid tumor). Patients are randomized to 1 of 4 treatment arms.
* Arm I: Patients receive epoetin alfa subcutaneously (SC) on day 1. Treatment repeats weekly for up to 15 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm I). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive epoetin alfa SC on day 1 (at a higher dose than in arm II). Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
* Arm IV: Patients receive darbepoetin alfa SC on day 1. Treatment repeats every 3 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity.
Hemoglobin levels are monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing is adjusted (e.g., held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within the desired ranges.
Quality of life is assessed at baseline and at weeks 4, 7, 10, 13, and 16.
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
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.
Epoetin alfa - 40000 units
40,000 Units
darbepoetin alfa
epoetin alfa
fatigue assessment and management
quality-of-life assessment
Epoetin alfa - 80000 units
80,000 Units
darbepoetin alfa
epoetin alfa
fatigue assessment and management
quality-of-life assessment
Epoetin alfa - 120000 Units
120,000 Units
darbepoetin alfa
epoetin alfa
fatigue assessment and management
quality-of-life assessment
Darbepoetin alfa***
500 mcg
darbepoetin alfa
epoetin alfa
fatigue assessment and management
quality-of-life assessment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
darbepoetin alfa
epoetin alfa
fatigue assessment and management
quality-of-life assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 1 year since prior peripheral blood stem cell, bone marrow, or cord blood transplantation
* More than 14 days since prior red blood cell transfusion
* More than 14 days since prior major surgery, including, but not limited to, any of the following:
* Amputation
* Invasion of a body cavity or of the central nervous system using a scalpel, saw, or laser cutting tool
* Resection of a body part (or parts), whether solid or liquid tissue or both, that includes ≥ 1% of a patient's preoperative weight
* The following are not considered major surgery:
* Diagnostic/therapeutic thoracentesis or paracentesis
* Diagnostic skin biopsy
* Digit or fingernail/thumbnail resection or laceration repair under local anesthesia
* Diagnostic fat aspiration
* Otic irrigation to remove cerumen impaction
* Tympanocentesis
* Uncomplicated dental extraction
* Uncomplicated tonsillectomy
* Laser corneal remodeling for refraction purposes
* Cosmetic or therapeutic eyelid surgery
* Bone marrow aspiration and biopsy
* More than 10 weeks since prior darbepoetin alfa, epoetin alfa, or any investigational form of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis stimulating protein)
* No planned stem cell transplantation within the next 4 months (18 weeks)
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Mayo Clinic
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.
Charles L. Loprinzi, M.D.
Role: STUDY_CHAIR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC05CB
Identifier Type: OTHER
Identifier Source: secondary_id
06-002991
Identifier Type: OTHER
Identifier Source: secondary_id
EPOANE3015
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000522677
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.