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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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epoetin alfa

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No