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
Information provided by:

May 28, 2002
May 29, 2002
September 15, 2008
January 2002
October 2003   (Final data collection date for primary outcome measure)
Time to first hemoglobin response during the treatment period [ Time Frame: during the treatment period ]
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Complete list of historical versions of study NCT00038064 on Archive Site
  • Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events [ Time Frame: throughout study ]
  • Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO) [ Time Frame: throughout study ]
  • Average weekly dosage of study drug during the 16-week treatment period [ Time Frame: 16-week treatment period ]
  • Receiving red blood cell (RBC) transfusion from week 5 to week 12 [ Time Frame: from week 5 to week 12 ]
  • Change in FACT-Fatigue scale score from baseline to week 7 [ Time Frame: from baseline to week 7 ]
  • Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise [ Time Frame: throughout study ]
  • Profile of change in FACT-Fatigue scale score from baseline over the treatment period [ Time Frame: from baseline over the treatment period ]
  • Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP) [ Time Frame: from baseline to EOTP ]
  • Change in FACT-Physical Well-being scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ]
  • Receiving RBC transfusion during the treatment period [ Time Frame: during the treatment period ]
  • Number of units of RBC transfused during the treatment period [ Time Frame: during the treatment period ]
  • Achieving a hemoglobin response by week 7 [ Time Frame: baseline to week 7 ]
  • Change in hemoglobin concentration from baseline to EOTP [ Time Frame: from baseline to EOTP ]
  • Time to first hematopoietic response [ Time Frame: throughout study ]
  • Achieving a hemoglobin correction [ Time Frame: throughout study ]
  • Number and percentage of subjects who exceed the hemoglobin concentration threshold [ Time Frame: throughout study ]
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Anemia in Patients With a Non-Myeloid Malignancy
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
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Neoplasms
  • Anemia
  • 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.
  • Drug: rHuEPO
    150 IU/kg TIW
  • Active Comparator: rHuEPO
    Intervention: Drug: rHuEPO
  • Experimental: Darbepoetin alfa
    Intervention: Drug: Darbepoetin alfa
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2004
October 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
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Global Development Leader, Amgen Inc.
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Study Director: MD Amgen
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP