Clinical trial · Interventional
Epoetin Alfa in Treating Anemia in Patients With Solid Tumors
A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer
NCT00058331CI-TRIAL-00023110completedPhase 3ClinicalTrials.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 stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia. PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.
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
- epoetin alfa - long term dosing
- description
- Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Then patients receive EPO SC once weekly for 18 weeks. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year.
- interventionNames
- Biological: epoetin alfa
- type
- EXPERIMENTAL
- label
- epoetin alfa - short term dosing
- description
- Patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment. Patients are followed every 6 months for 1 year.
- interventionNames
- Biological: epoetin alfa
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)
* Anemia secondary to cancer or cancer treatment\*
* Hemoglobin less than 12 g/dL (males)
* Hemoglobin less than 11 g/dL (females) NOTE: \*Active anticancer therapy is not required for study enrollment
* Anemia must not be secondary to any of the following:
* B\_12, folic acid, or iron deficiency
* Ferritin must be normal or elevated
* Gastrointestinal bleeding or hemolysis
* Primary or chemotherapy-induced myelodysplastic syndromes
* No untreated CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 6 months
Cardiovascular
* No history of uncontrolled cardiac arrhythmias
* No history of deep venous thrombosis within the past year (unless on anticoagulation)
* No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)
Pulmonary
* No history of pulmonary embolism within the past year (unless on anticoagulation)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin
* No new onset of seizures within the past 3 months
* No poorly controlled seizures
* Able and willing to complete quality of life forms
* Alert and mentally competent to give informed consent
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 6 months since prior epoetin alfa
* More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)
* No concurrent peripheral blood stem cell transplantation
* No concurrent bone marrow transplantation
Surgery
* More than 14 days since prior major surgery
Other
* More than 2 weeks since prior red blood cell transfusionsReferences
Publications (2)
- RESULTSteensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol. 2006 Mar 1;24(7):1079-89. doi: 10.1200/JCO.2005.02.7276. PMID 16505427
- RESULTSteensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005.