Status:
COMPLETED
A Study of the Effectiveness and Safety of Treatment With Epoetin Alfa on Hemoglobin Levels, Red Blood Cell Transfusions, and Quality of Life in Patients With Cancer Receiving Platinum-containing Chemotherapy
Lead Sponsor:
Janssen-Cilag B.V.
Conditions:
Anemia
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the ...
Detailed Description
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, due in part to the tiredness associated with anemia. Previous studies with e...
Eligibility Criteria
Inclusion
- Patients having a confirmed diagnosis of cancer and are planned to receive platinum chemotherapy with a minimum of 8 weeks on study and a maximum of 6 or 12 cycles
- Eastern Cooperative Oncology Group (a scale used by researchers to represent the level of activity that a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 3 (capable of only limited self-care, confined to bed or chair \>50% of waking hours)
- life expectancy of \>=5 months
- have a hemoglobin value of \<=7.5 grams per deciliter at any time during or prior to chemotherapy
Exclusion
- Patients having clinically significant disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurological, gastrointestinal, or genitourinary systems that is not due to cancer or chemotherapy (this disease/dysfunction is only an exclusion criterion if it causes an expected early withdrawal from the study)
- uncontrolled high blood pressure
- history of seizures
- untreated iron, folate, or vitamin B12 deficiency
- received androgen (e.g., testosterone) therapy within 2 months of study entry, had a major illness within 7 days of study entry, or a major infection within 1 month of study entry
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT00283465
Start Date
November 1 1999
End Date
April 1 2004
Last Update
January 14 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.