Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer (NCT00255749) | Clinical Trial Compass
CompletedPhase 2
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
United States89 participantsStarted 2005-08
Plain-language 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.
Who can participate
Age range18 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:
* 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 pulmonar…