Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 al...
Detailed Description
Patients undergoing treatment with adriamycin-containing chemotherapy frequently develop significant anemia. Agents that can increase the amount of hemoglobin in cancer patients undergoing treatment w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 1990
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00266617
End Date
June 1 1990
Last Update
May 18 2011
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