Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Patients With Persistent Anemia as a Result of Cancer Treatment With Cisplatin, a Platinum-containing Chemotherapy Drug
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 versus placebo in the treatment of persistent anemia caused by advanced cancer and aggressive cisplatin chemothera...
Detailed Description
Patients undergoing treatment with cisplatin-containing chemotherapy frequently develop significant anemia (hemoglobin \<= 10.5 grams/deciliter). Agents that can increase the amount of hemoglobin in c...
Eligibility Criteria
Inclusion
- Patients with cancer (except for rapid onset of severe leukemia and malignancies of the bone marrow and spleen) and having anemia resulting from cisplatin-containing chemotherapy
- receiving cyclic chemotherapy for \<=5 consecutive days every 3 or 4 weeks (for 3 cycles of chemotherapy)
- Performance score of 0, 1, 2, or 3 (grades assessing patients' ability to perform daily activities)
- having a life expectancy of at least 3 months
- having a hemoglobin level \<= 10.5 grams/deciliter, and signs and symptoms of physical stability for 1 month before the study (based on physical examination including vital signs, weight, and electrocardiogram)
- with an 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
- receiving radiation therapy or surgery to decrease the number of cancer cells within 30 days before the start of the study
- having a sudden and severe onset of illness within 7 days before the start of the study
- having cancer that has spread to the brain, a history of seizures, uncontrolled high blood pressure, or an iron, folate, or vitamin B12 deficiency
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1990
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00269997
End Date
July 1 1990
Last Update
May 18 2011
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