Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy (NCT00416624) | Clinical Trial Compass
CompletedPhase 2
Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy
United States239 participantsStarted 2007-05
Plain-language summary
RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer.
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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Diagnosis of solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell dyscrasia or lymphoproliferative disorder)
* No nonmelanomatous skin cancer
* Hemoglobin ≤ 10.5 g/dL
* Ferritin \> 20 ng/mL (i.e., not obviously iron deficient)
* Planning to receive ≥ 12 weeks of anticancer chemotherapy
* Biological therapy (e.g., hypomethylating agents, monoclonal antibodies, or small molecule pathway inhibitors) with an individual or cumulative regimen incidence of grade 3 or 4 anemia \> 10% is considered chemotherapy for purposes of this study
* No known anemia secondary to any of the following:
* Cyanocobalamin (vitamin B\_12) or folic acid deficiency
* Gastrointestinal bleeding within the past 2 weeks
* Hemolysis
* Myelodysplastic syndromes, myeloproliferative disorders, or acute myeloid leukemia
* No primary hematologic disorder causing chronic moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major)
* Carriers of these disease states allowed provided they are not anemic prior to cancer diagnosis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 6 months
* Not pregnant or nursing
* No delivery of a baby of ≥ 18 weeks estimated gestational age within the past 3 months (90 days)
* Negative pregnancy test
* Fertile patients must use effective contraception
* Weight \> 40.0 kg and \< 150.0 kg
* …
What they're measuring
1
The Percentage of Participants Who Exhibit a Hematopoietic Response