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NCT Number: NCT00038064

Anemia in Patients With a Non-Myeloid Malignancy

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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Key information

Conditions

Neoplasms Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

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.

rHuEPO

Drug

150 IU/kg TIW

Primary outcomes

  1. Time to first hemoglobin response during the treatment period

    Time frame: during the treatment period

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2004
First posted
May 29, 2002
Registry last updated
Sep 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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