Epoetin Alfa for Anemia in Patients With Cancer Receiving Non-platinum Chemotherapy
Double-Blind, Placebo-Controlled Study to Assess the Effect of Early Intervention and/or Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing Chemotherapy
1 other identifier
interventional
375
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness of epoetin alfa versus placebo in reducing or preventing the need for transfusions in anemic patients with non-myeloid cancer on non-platinum chemotherapy, and to investigate quality-of-life benefits associated with the use of epoetin alfa. 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_3
Started Aug 1996
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 Start
First participant enrolled
August 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 1998
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 26, 2005
CompletedMay 18, 2011
January 1, 2011
December 22, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients transfused after one month
Secondary Outcomes (1)
Changes in hemoglobin, hematocrit, and developing red blood cells from the start of the study until study completion; Changes in quality-of-life; Safety
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of non-myeloid malignancy
- undergoing treatment with non-platinum-containing chemotherapy, or non-platinum-containing chemotherapy is imminent
- Eastern Cooperative Oncology Group (which is a scale used by researchers to represent the level of activity that a patient is capable of) 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)
- life expectancy of at least 6 months
- baseline hemoglobin \<= 10.5 grams per deciliter (or a fall in hemoglobin level \>= 1.5 grams per deciliter per cycle or per month since the beginning of the current course of chemotherapy such that it dropped to \<= 12 grams per deciliter) and baseline count of \<125,000 microliters for developing red cells
You may not qualify if:
- Patients having a clinically significant disease other than cancer
- treated by platinum-containing chemotherapy within 3 months of study start
- having uncontrolled high blood pressure, a history of seizure, or untreated iron, folate, or Vitamin B12 deficiency
- received a transfusion or radiotherapy within 2 weeks of study start, or had surgery within 1 week of study start
- intending to use steroid drugs during 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 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Start
August 1, 1996
Study Completion
September 1, 1998
Last Updated
May 18, 2011
Record last verified: 2011-01