Status:
COMPLETED
Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare hemoglobin (Hgb) response rates between epoetin alfa (PROCRIT; 40,000 Units (U) SC weekly) and darbepoetin alfa (ARANESP; 200 mcg every other week) in anemic ca...
Detailed Description
Chemotherapy related anemia occurs in a majority of cancer patients and can cause impaired treatment outcomes, increased treatment-related complications and altered quality of life. Epoetin alfa admin...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of a solid tumor malignancy
- Baseline hemoglobin value of \<11 g/dL
- Scheduled to receive cyclic chemotherapy for a minimum of 12 weeks
- \< 2 prior chemotherapy regimens in a metastatic setting
- Adequate hematologic \& renal function and platelet count \>100,000/mm3
- Estimated life expectancy of \> 6 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
Exclusion
- History of stem cell or bone marrow transplant
- Anemia due to factors other than cancer/chemotherapy
- Prior treatment with epoetin alfa or darbepoetin alfa or any investigational forms of erythropoietin within the previous 3 months
- Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying malignancy or chemotherapy
- Uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis
- new onset of seizures
- history of second active malignancy
- Major infection requiring hospitalization and antibiotics within 14 days of randomization
- Transfusion of white blood cells or packed red blood cells within 28 days of randomization.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT00315484
Start Date
February 1 2003
End Date
October 1 2004
Last Update
May 19 2011
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