Hematologic Response of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) in Chemotherapy Induced Anemia

This study has been completed.
Sponsor:
Information provided by:
Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:
NCT00315484
First received: April 14, 2006
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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 cancer patients receiving chemotherapy.


Condition Intervention Phase
Anemia
Chemotherapy
Drug: Epoetin alfa and Darbepoetin alfa
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study Of Epoetin Alfa (PROCRIT) Versus Darbepoetin Alfa (ARANESP) To Evaluate Hematologic Response Rate In Anemic Cancer Patients Receiving Chemotherapy

Resource links provided by NLM:


Further study details as provided by Ortho Biotech Products, L.P.:

Primary Outcome Measures:
  • The primary efficacy endpoint will evaluate the proportion of patients achieving >1 g/dL hemoglobin increase by week 5.

Secondary Outcome Measures:
  • 1) time to hemoglobin (Hgb) increase of 1g/dL; 2) proportion of pts achieving a >1 g/dL Hgb increase by Wk 9; 3) proportion of pts achieving a >2g/dL Hgb increase by Wk 9; 4) Hgb values over time; 5) cumulative RBC transfusion Wk 5 to end of study

Enrollment: 358
Study Start Date: February 2003
Study Completion Date: October 2004
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315484

Sponsors and Collaborators
Ortho Biotech Products, L.P.
Investigators
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech Products, L.P.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00315484     History of Changes
Other Study ID Numbers: CR004609
Study First Received: April 14, 2006
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho Biotech Products, L.P.:
Anemia
chemotherapy
hemoglobin level
recombinant human erythropoietin
epoetin alfa
darbepoetin alfa

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014