An Efficacy and Safety Study of Epoetin Alfa (PROCRIT) Initiated at 40,000 Units Every Week Versus 80,000 Units Every Two Weeks in Anemic Patients With Cancer Receiving Chemotherapy.

A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Initiated At 40,000 Units Every Week Versus 80,000 Units Every Two Weeks In Anemic Patients With Cancer Receiving Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00210834

Enrollment

310

Registered

2005-09-21

Start date

2004-05-31

Completion date

2005-09-30

Last updated

2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

PROCRIT, Erythropoietin, Epoetin alfa, Hemoglobin level

Brief summary

The primary objective of this study is to compare end of study hemoglobin levels between Epoetin alfa at 40,000 units administered subcutaneously once every week and at 80,000 units subcutaneously every two weeks in anemic patients with cancer receiving chemotherapy. The secondary objectives of the study are to assess the Hb response, time to Hb response, transfusion requirements, and safety.

Detailed description

This is a randomized, open-label, multi-center study to compare end of study hemoglobin level between Epoetin alfa (PROCRIT) at 40,000 units administered subcutaneously once every week (qw) and at 80,000 units subcutaneously every two weeks (q2w) in approximately 280 anemic patients with cancer receiving chemotherapy. The study hypothesis is that a dosing regimen of PROCRIT 80,000 Units q2w subcutaneously (sc) is non-inferior to a dosing regimen of PROCRIT 40,000 Units qw sc with respect to the change in hemoglobin (Hb) from baseline to Study Week 13 for patients with chemotherapy associated anemia and this respective dosing regimen is generally well-tolerated. The patients will receive subcutaneous (under the skin) injections of Epoetin alfa (PROCRIT) at one of the following dosing regimens: 1- Starting dose of 40,000 units sc qw (once every week) OR 2- Starting dose of 80,000 units sc q2w (every two weeks)

Interventions

DRUGepoetin alfa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed diagnosis of non-myeloid malignancy * Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion * Planned chemotherapy for a minimum of 12 weeks during the study * Life expectancy of \>= 6 months * ECOG Performance Status 0-2

Exclusion criteria

* Diagnosis of a myeloid malignancy or known history of myelodysplasia * Planned non-palliative radiation during the study * Anemia due to factors other than cancer/chemotherapy * Prior treatment with Epoetin alfa or any other erythropoietic agent within the previous three months * History 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

Design outcomes

Primary

Measure	Time frame
The end of study Hb. The end of study Hb is defined as the patient's final Hb level, taken 2 weeks after the last dose of PROCRIT or at Week 13, whichever comes first.	—

Secondary

Measure	Time frame
Time to 1 g/dL HB increase; Proportion of patients achieving a >= 1 g/dL Hb increase by week for Weeks 5-13; Time to Hb increase of 2 g/dL or achieving Hb of >= 12 g/dL; Proportion of patients achieving a >= 2 g/dL Hb increase or Hb of 12 g/dL by EOS	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026