NCT00083486

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

April 27, 2011

Status Verified

April 1, 2011

First QC Date

May 24, 2004

Last Update Submit

April 25, 2011

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Heritage Physician Group-Oncology

Hot Springs, Arkansas, 71913, United States

Location

Spalding Oncology Services

Griffin, Georgia, 30224, United States

Location

Southern Illinois Hematology

Centralia, Illinois, 62801, United States

Location

BioLab Research

Rockville, Maryland, 20852, United States

Location

Slocum-Dickson Medical Group, PC

New Hartford, New York, 13413, United States

Location

NorthEast Urology Research

Concord, North Carolina, United States

Location

Mid Ohio Oncology Hematology

Columbus, Ohio, 43213, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Caroline Cancer Center

Aiken, South Carolina, 29403, United States

Location

Charleston Hematology Oncology

Charleston, South Carolina, 29403, United States

Location

Charleston Cancer Care

Charleston, South Carolina, 29406, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2004

First Posted

May 27, 2004

Study Start

February 1, 2004

Study Completion

October 1, 2004

Last Updated

April 27, 2011

Record last verified: 2011-04

Locations