Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy

NCT ID: NCT00083486

Last Updated: 2011-04-27

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

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2004-10-31

Brief Summary

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The purpose of this study is to determine the effectiveness of different doses of epoetin alfa for treating anemia in patients who have cancer; or patients who no longer have any signs of cancer, but remain anemic as a result of their treatment. These patients should not be currently receiving chemotherapy or radiotherapy. A subject's participation in the study will last approximately 6 months. Subjects will receive weekly doses of epoetin alfa or placebo. Their hemoglobin will be tested every week.

Detailed Description

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Conditions

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Anemia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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epoetin alfa

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight \>/=99 lbs
* ECOG 0-2
* Anemia results from cancer, chemotherapy, radiotherapy or an association with hormonal therapy or immunotherapy
* Screening hemoglobin level of \</=11.0 g/dL for men or \</=10.0 for women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Locations

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Heritage Physician Group-Oncology

Hot Springs, Arkansas, United States

Site Status

Spalding Oncology Services

Griffin, Georgia, United States

Site Status

Southern Illinois Hematology

Centralia, Illinois, United States

Site Status

BioLab Research

Rockville, Maryland, United States

Site Status

Slocum-Dickson Medical Group, PC

New Hartford, New York, United States

Site Status

NorthEast Urology Research

Concord, North Carolina, United States

Site Status

Mid Ohio Oncology Hematology

Columbus, Ohio, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Caroline Cancer Center

Aiken, South Carolina, United States

Site Status

Charleston Hematology Oncology

Charleston, South Carolina, United States

Site Status

Charleston Cancer Care

Charleston, South Carolina, United States

Site Status

Volunteer Research Group

Knoxville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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EPO-CAN-203

Identifier Type: -

Identifier Source: secondary_id

CR010939

Identifier Type: -

Identifier Source: org_study_id

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