A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy
18 Years
N/A
Both
Anemia, Chemotherapy
Trial Information
A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy
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 administered on a weekly dosing schedule of 40,000 Units subcutaneously ([SC],
under the skin) with dose adjustments based on hematologic response produces significant
improvement in hemoglobin levels, decreased transfusion frequency and improved quality of
life. It is unknown if the recently developed agent, darbepoetin alfa, administered on an
every other week fixed dose will produce similar improvements in hematologic and quality of
life outcomes. Thus, further randomization studies are warranted utilizing once weekly
dosing (QW) of Epoetin alfa compared to once every other week (Q2W) darbepoetin alfa.
Patients will receive study medications for up to 16 weeks.Safety & efficacy evaluations
will be performed at specified intervals throughout the study.The study hypothesis is that
the Week 5 hemoglobin response rate in the Epoetin alfa group is better than that in the
Darbepoetin alfa group. The starting dose for study drug is either Epoetin alfa (PROCRIT)
40,000 Units SC QW or Darbepoetin alfa (ARANESP) 200 mcg SC Q2W. Doses may be adjusted
depending on the patient's hemoglobin levels up a maximum of 60,000 IU SC QW Epoetin alfa or
300 mcg SC Q2W Darbepoetin alfa.
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary efficacy endpoint will evaluate the proportion of patients achieving >1 g/dL hemoglobin increase by week 5.
Principal Investigator
Ortho Biotech Products, L.P. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Ortho Biotech Products, L.P.
Authority:
United States: Institutional Review Board
Study ID:
CR004609
NCT ID:
NCT00315484
Start Date:
February 2003
Completion Date:
October 2004
Related Keywords:
- Anemia
- Chemotherapy
- Anemia
- chemotherapy
- hemoglobin level
- recombinant human erythropoietin
- epoetin alfa
- darbepoetin alfa
- Anemia
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