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A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy

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What is being tested

Data Collection

Who is being recruted

Anemia

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2003
See protocol details

Summary

Principal SponsorOrtho Biotech Products, L.P.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2003

Actual date on which the first participant was enrolled.

Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa administered on a weekly dosing schedule of 40,000 Units subcutaneously (\[SC\], under the skin) with dose adjustments based on hematologic response produces significant improvement in hemoglobin levels, decreased transfusion frequency and improved quality of life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an every other week fixed dose will produce similar improvements in hematologic and quality of life outcomes. Thus, further randomization studies are warranted utilizing once weekly dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa. Patients will receive study medications for up to 16 weeks.Safety \& efficacy evaluations will be performed at specified intervals throughout the study.The study hypothesis is that the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT) 40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or 300 mcg SC Q2W Darbepoetin alfa.

Official TitleA Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy
NCT00315484
Principal SponsorOrtho Biotech Products, L.P.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

358 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaHematologic DiseasesHemic and Lymphatic Diseases

Criteria

7 inclusion criteria required to participate
Histologically confirmed diagnosis of a solid tumor malignancy
Baseline hemoglobin value of <11 g/dL
Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks
2 prior chemotherapy regimens in a metastatic setting
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9 exclusion criteria prevent from participating
History of stem cell or bone marrow transplant
Anemia due to factors other than cancer/chemotherapy
Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 months
Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers
A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy | PatLynk