Clinical trial · Interventional
Alternate Dosing of PROCRIT (Epoetin Alfa) in Patients With Cancer and Chemotherapy Induced Anemia
An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)
- 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 was to test the effectiveness and safety of PROCRIT (Epoetin alfa) at a higher starting dose (60,000 Units) once per week, followed by a less frequent dose (60,000 Units every two weeks) in patients with cancer and chemotherapy induced anemia.
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 | — |
| Chemotherapy | — | UNRESOLVED | — |
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 with a >= 1 g/dL increase in Hb above baseline in Phase A independent of transfusion within 4 weeks
Secondary outcomes (1)
- measure
- Phase B: Maintain or increase the absolute Hb level achieved in Phase A (up to 0.9 g/dL higher) or maintain or increase the Hb level above that achieved in Phase A independent of transfusion within 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of non-myeloid malignancy (no history of myelodysplasia allowed) with a baseline hemoglobin of \<= 11 g/dL, planned to receive chemotherapy for a minimum of 12 weeks * Life expectancy of \>= 6 months with an Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 * Negative serum pregnancy test at Screening and adequate contraceptive during treatment and for three months after treatment * Adequate hematologic function, adequate renal function and adequate hepatic function. Exclusion Criteria: * Planned radiation during the study * Anemia due to factors other than cancer/chemotherapy (i.e., iron, B12 or folate deficiencies, hemolysis or gastrointestinal bleeding) * Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g., Darbepoetin alfa) within the previous three months * Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy, uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis * Transfusion of platelets or packed red blood cells within 28 days prior to the first dose of study medication * Planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell transplant during study duration.
References
Publications (0)
Data not yet available