Clinical trial · Interventional
PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy
A Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy
NCT00388336CI-TRIAL-00004874completedPhase 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 effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who 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
- The primary endpoint was to evaluate hematopoietic response, defined as >= 2 g/dL Hb increase from baseline and/or Hb >= 12 g/dL over the course of the study and independent of transfusion within 28 days.
Secondary outcomes (1)
- measure
- Secondary endpoints included the effects of PROCRIT (Epoetin alfa) on transfusion requirements, on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) and FACT-An tools as well as time to hemoglobin response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have 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 16-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. Exclusion Criteria: * Patients must not have uncontrolled hypertension or a history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder * No transfusion within 28 days prior to first dose * No 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.