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Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy

Primary Purpose

Anemia, Cancer

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 focused on measuring Anemia, Cancer

Eligibility Criteria

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

Inclusion Criteria: 18 years of age or older Body weight >/= 99lbs 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 Exclusion Criteria: History of or concurrent second malignancy Evidence of primary or metastatic malignancy involving the Central Nervous System

Sites / Locations

  • Advanced Urology Medical Center
  • Shapiro, Stafford & Yee
  • California Cancer Center
  • Tukoi Research
  • Hanover Medical Specialists, PA
  • Madigan Army Medical Center Urology Services

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
NCT00083434
Brief Title
Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Terminated
Why Stopped
This study was stopped because of an inadequate rate of enrollment.
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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine the effectiveness of epoetin alfa in treating anemia in patients who have cancer or who no longer have any signs of the cancer, but remain anemic as a result of their treatment.

6. Conditions and Keywords

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

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: 18 years of age or older Body weight >/= 99lbs 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 Exclusion Criteria: History of or concurrent second malignancy Evidence of primary or metastatic malignancy involving the Central Nervous System
Facility Information:
Facility Name
Advanced Urology Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Shapiro, Stafford & Yee
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
California Cancer Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Tukoi Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Hanover Medical Specialists, PA
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Madigan Army Medical Center Urology Services
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-5000
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Description
FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
URL
http://dailymed.nlm.nih.gov/dailymed/about.cfm
Description
Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfm

Learn more about this trial

Treatment of Anemic Patients With Cancer Who Are Not Receiving Chemotherapy or Radiotherapy

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