Clinical trial · Interventional
A Study to Evaluate the Hematologic Response Rate (the Rate at Which the Hemoglobin Level Rises) of PROCRIT (Epoetin Alfa) Given at a Dose of 80,000 Units Once Weekly to Cancer Patients With Anemia Who Are Receiving Chemotherapy.
A Pilot Study to Evaluate the Hematologic Response Rate of PROCRIT� (Epoetin Alfa) at 80,000 Units Once Weekly in Anemic Cancer Patients Receiving Chemotherapy
NCT00341055CI-TRIAL-00004984completedPhase 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 hematologic response, safety, and clinical outcomes of PROCRIT administered once a week in anemic cancer patients receiving chemotherapy.
Conditions
Conditions (3)
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 | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary efficacy endpoint was major response defined as the proportion of patients with >= 2 g/dL hemoglobin (Hb) increase from baseline or Hb >= 12 g/dL and independent of transfusion within 28 days.
Secondary outcomes (1)
- measure
- The secondary efficacy endpoint was minor response defined as the proportion of patients with >= 1 g/dL hemoglobin (Hb) increase from baseline (up to 1.9 g/dL increase) and incidence of transfusion and independent of transfusion within 28 days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a confirmed diagnosis of any non-myeloid malignancy planned to have received at least 12 weeks of chemotherapy with hemoglobin \<= 11 g/dL * Life expectancy \> 6 months with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Both male and female patients with reproductive potential must have used an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment. Female patients with reproductive potential had a negative serum pregnancy test within 7 days of the first dose of study drug. Exclusion Criteria: * Previous radiation therapy to \> 25% bone marrow reserve or planned radiation during study duration * Packed red blood cells (PRBC) transfusion within 28 days of study entry * Anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, Vitamin B12 deficiency, hemolysis or GI bleeding * Previous treatment with Epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin, novel erythropoiesis stimulating protein) within the previous 3 months * uncontrolled hypertension or history of thrombotic vascular events
References
Publications (0)
Data not yet available
No reference posted for this study.