Clinical trial · Interventional
The Effect of Epoetin Alfa on the Anemia of Patients With Selected Cancers Receiving Chemotherapy
A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy
NCT00270166CI-TRIAL-00004875completedPhase 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)
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with cancer receiving chemotherapy, and to investigate possible quality-of-life benefits associated with the use of epoetin alfa. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Conditions
Conditions (9)
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 | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma, Small Cell Lung | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Esophagus Cancer | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients without transfusion after first month.
Secondary outcomes (1)
- measure
- Proportion of responders, change of hemoglobin (not by transfusion), cumulative transfusion rate, proportion of patients transfused during the double-blind phase, excluding the first month; mean change score of baseline quality of life parameters; safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer, small-cell lung cancer, esophagus cancer, or prostate cancer * receiving treatment with chemotherapy, with at least 3 additional months of chemotherapy planned * a self-care performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours) * life expectancy of at least 6 months * baseline hemoglobin \<12 grams per deciliter and baseline count of \<100,000 microliter for developing red cells Exclusion Criteria: * Clinically significant disease other than cancer * evidence of uncontrolled hypertension or history of seizure * transfusion within 1 week of the study * radiotherapy within 2 weeks of study start * use of corticosteroid or steroid drugs during the study.
References
Publications (0)
Data not yet available
No reference posted for this study.