Anemia in Patients With a Non-Myeloid Malignancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038064
Recruitment Status : Completed
First Posted : May 29, 2002
Last Update Posted : September 15, 2008
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Brief Summary:
Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.

Condition or disease Intervention/treatment Phase
Neoplasms Anemia Drug: Darbepoetin alfa Drug: rHuEPO Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 707 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy
Study Start Date : January 2002
Actual Primary Completion Date : October 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: rHuEPO Drug: rHuEPO
150 IU/kg TIW
Experimental: Darbepoetin alfa Drug: Darbepoetin alfa
Darbepoetin alfa will be administered 4.5 mcg/kg QW until hemoglobin correction is achieved. Subjects meeting hemoglobin criteria for correction will receive a maintenance dose of darbepoetin alfa of 4.5 mcg/kg Q3W.

Primary Outcome Measures :
  1. Time to first hemoglobin response during the treatment period [ Time Frame: during the treatment period ]

Secondary Outcome Measures :
  1. Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events [ Time Frame: throughout study ]
  2. Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO) [ Time Frame: throughout study ]
  3. Average weekly dosage of study drug during the 16-week treatment period [ Time Frame: 16-week treatment period ]
  4. Receiving red blood cell (RBC) transfusion from week 5 to week 12 [ Time Frame: from week 5 to week 12 ]
  5. Change in FACT-Fatigue scale score from baseline to week 7 [ Time Frame: from baseline to week 7 ]
  6. Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise [ Time Frame: throughout study ]
  7. Profile of change in FACT-Fatigue scale score from baseline over the treatment period [ Time Frame: from baseline over the treatment period ]
  8. Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP) [ Time Frame: from baseline to EOTP ]
  9. Change in FACT-Physical Well-being scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ]
  10. Receiving RBC transfusion during the treatment period [ Time Frame: during the treatment period ]
  11. Number of units of RBC transfused during the treatment period [ Time Frame: during the treatment period ]
  12. Achieving a hemoglobin response by week 7 [ Time Frame: baseline to week 7 ]
  13. Change in hemoglobin concentration from baseline to EOTP [ Time Frame: from baseline to EOTP ]
  14. Time to first hematopoietic response [ Time Frame: throughout study ]
  15. Achieving a hemoglobin correction [ Time Frame: throughout study ]
  16. Number and percentage of subjects who exceed the hemoglobin concentration threshold [ Time Frame: throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug
  • Screening hemoglobin concentration less than or equal to 11.0 g/dL
  • ECOG performance status of 0 to 2 (inclusive)

Exclusion Criteria:

  • History of seizure disorder
  • Primary hematologic disorder that could cause anemia
  • Unstable or uncontrolled disease/condition related to or affecting cardiac function
  • Clinical evidence of chronic infection/inflammatory disease
  • Positive test for HIV infection
  • Previously confirmed neutralizing antibodies to rHuEPO
  • Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038064

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00038064     History of Changes
Obsolete Identifiers: NCT00046982
Other Study ID Numbers: 20010101
First Posted: May 29, 2002    Key Record Dates
Last Update Posted: September 15, 2008
Last Verified: September 2008

Keywords provided by Amgen:
anemia of cancer/chemotherapy
non-myeloid malignancies
Drug Therapy

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa
Epoetin Alfa