Clinical trial · Interventional
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy
NCT00255749CI-TRIAL-00008205completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- early intervention epoietin alfa
- description
- Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
- interventionNames
- Biological: epoetin alfa
- type
- OTHER
- label
- standard intervention epoietin alfa
- description
- Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.
- interventionNames
- Biological: epoetin alfa
Primary outcomes (2)
- measure
- Efficacy
- timeFrame
- 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGlaspy 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. PMID 19170225