Clinical trial · Interventional
A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Patients With Persistent Anemia as a Result of Cancer Treatment With Cisplatin, a Platinum-containing Chemotherapy Drug
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Cisplatin Chemotherapy
NCT00269997CI-TRIAL-00004867completedPhase 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)
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in the treatment of persistent anemia caused by advanced cancer and aggressive cisplatin chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Conditions
Conditions (2)
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 | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of transfusions required; Changes in hemoglobin, hematocrit, and reticulocyte (immature red blood cells) levels from before the study to the end of the study
Secondary outcomes (1)
- measure
- Quality of life assessment; Physician's global evaluation; Performance score (ability to perform daily activities); Assessment of safety (laboratory tests, vital signs, and adverse events) from before the study to the end of the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cancer (except for rapid onset of severe leukemia and malignancies of the bone marrow and spleen) and having anemia resulting from cisplatin-containing chemotherapy * receiving cyclic chemotherapy for \<=5 consecutive days every 3 or 4 weeks (for 3 cycles of chemotherapy) * Performance score of 0, 1, 2, or 3 (grades assessing patients' ability to perform daily activities) * having a life expectancy of at least 3 months * having a hemoglobin level \<= 10.5 grams/deciliter, and signs and symptoms of physical stability for 1 month before the study (based on physical examination including vital signs, weight, and electrocardiogram) * with an ability to administer self-injections Exclusion Criteria: * Patients with a history of any blood disease * having signs and symptoms of significant disease/dysfunction not caused by the underlying cancer * receiving radiation therapy or surgery to decrease the number of cancer cells within 30 days before the start of the study * having a sudden and severe onset of illness within 7 days before the start of the study * having cancer that has spread to the brain, a history of seizures, uncontrolled high blood pressure, or an iron, folate, or vitamin B12 deficiency
References
Publications (0)
Data not yet available
No reference posted for this study.