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

Primary Purpose

Anemia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
epoetin alfa
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heritage Physician Group-Oncology
  • Spalding Oncology Services
  • Southern Illinois Hematology
  • BioLab Research
  • Slocum-Dickson Medical Group, PC
  • NorthEast Urology Research
  • Mid Ohio Oncology Hematology
  • Drexel University College of Medicine
  • Caroline Cancer Center
  • Charleston Hematology Oncology
  • Charleston Cancer Care
  • Volunteer Research Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 24, 2004
Last Updated
April 25, 2011
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00083486
Brief Title
Treatment of Anemia in Patients With Cancer Who Are Not Currently Receiving Chemotherapy or Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epoetin alfa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Heritage Physician Group-Oncology
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Spalding Oncology Services
City
Griffin
State/Province
Georgia
ZIP/Postal Code
30224
Country
United States
Facility Name
Southern Illinois Hematology
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
BioLab Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Slocum-Dickson Medical Group, PC
City
New Hartford
State/Province
New York
ZIP/Postal Code
13413
Country
United States
Facility Name
NorthEast Urology Research
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Mid Ohio Oncology Hematology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Caroline Cancer Center
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Charleston Cancer Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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