Clinical trial · Interventional
An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation
A Pilot Study to Evaluate the Response Rate of Epoetin Alfa (PROCRIT) at 80,000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy
NCT00210587CI-TRIAL-00004990completedPhase 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 effectiveness and safety of epoetin alfa (PROCRIT®) administered 80,000 Units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy.
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
- Percent of patients that achieved a hematopoietic response, defined as a Hb increase >= 2 g/dL and/or Hb = 12 g/dL during the study independent of transfusion within 28 days
Secondary outcomes (1)
- measure
- Transfusion requirements, change in Quality of Life scores measured by LASA & FACT-An, mean time to hematopoietic response (defined in Primary Endpoint) & mean time to >= 1g/dL change in Hb from baseline. Incidence of adverse events for study duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of non-myeloid malignancy * Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion * Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 13-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable * Female patients with reproductive potential must have a negative serum pregnancy test at screening * Patients must have signed an informed consent Exclusion Criteria: * Uncontrolled hypertension * History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder * Transfusion within 28 days prior to first dose * Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry * No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months
References
Publications (0)
Data not yet available
No reference posted for this study.