A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa in Patients With Anemia as a Result of Advanced Cancer and Treatment With Aggressive Chemotherapy
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Chemotherapy
1 other identifier
interventional
86
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa in the treatment of persistent anemia caused by advanced cancer and aggressive adriamycin-chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
June 1, 1990
CompletedFirst Submitted
Initial submission to the registry
December 16, 2005
CompletedFirst Posted
Study publicly available on registry
December 19, 2005
CompletedMay 18, 2011
April 1, 2010
December 16, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of transfusions; Change from baseline in levels of hemoglobin, hematocrit, reticulocytes (immature red blood cells)
Secondary Outcomes (1)
Change from baseline to end of study in: Quality of life; Physician's Global Evaluation of Study Medication; Patient's performance scores (energy level and daily activities); Assessment of safety
Interventions
Eligibility Criteria
You may qualify if:
- Patients with cancer (except for rapid onset of severe leukemia and malignancies of the bone marrow and spleen) and anemia resulting from non-cisplatin-containing chemotherapy who are receiving cyclic chemotherapy for \<=5 consecutive days every 3 or 4 weeks (for 3 cycles of chemotherapy)
- having a Performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a self-care performance score of 0 \[fully active, no disease restriction\] to 3 \[capable of only limited self-care, confined to bed or chair more than 50% of waking hours\])
- having a life expectancy of at least 3 months
- with signs and symptoms of physical stability for 1 month before the study, (based on physical examination including vital signs, weight, and electrocardiogram), not grossly obese, and having a hemoglobin \<= 10.5 grams/deciliter (g/dL)
- who are able to demonstrate the ability to administer self-injections
You may not qualify if:
- Patients with a history of any blood disease
- having signs and symptoms of significant disease/dysfunction not caused by the underlying cancer
- having a spread of cancer to the brain
- having uncontrolled high blood pressure, an iron, folate or vitamin B12 deficiency, or a history of seizures
- received therapy with androgen within 2 months before the start of study, received radiation therapy or surgery to decrease the number of cancer cells within 30 days before the start of the study, or experienced sudden and severe onset of illness within 7 days before the start of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 16, 2005
First Posted
December 19, 2005
Study Completion
June 1, 1990
Last Updated
May 18, 2011
Record last verified: 2010-04