Anemia in Patients With a Non-Myeloid Malignancy

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00038064
First received: May 28, 2002
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Neoplasms
Anemia
Drug: Darbepoetin alfa
Drug: rHuEPO
Phase 3

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 Darbepoetin Alfa (Novel Erythropoiesis Stimulation Protein, NESP) and rHuEPO for the Treatment of Anemia in Subjects With Non-Myeloid Malignancies Receiving Multicycle Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to first hemoglobin response during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO) [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Average weekly dosage of study drug during the 16-week treatment period [ Time Frame: 16-week treatment period ] [ Designated as safety issue: Yes ]
  • Receiving red blood cell (RBC) transfusion from week 5 to week 12 [ Time Frame: from week 5 to week 12 ] [ Designated as safety issue: No ]
  • Change in FACT-Fatigue scale score from baseline to week 7 [ Time Frame: from baseline to week 7 ] [ Designated as safety issue: No ]
  • Percentage of subjects who have a rapid rate of hemoglobin concentration rise and negative clinical consequences associated with this rise [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Profile of change in FACT-Fatigue scale score from baseline over the treatment period [ Time Frame: from baseline over the treatment period ] [ Designated as safety issue: No ]
  • Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP) [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Change in FACT-Physical Well-being scale score from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Receiving RBC transfusion during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
  • Number of units of RBC transfused during the treatment period [ Time Frame: during the treatment period ] [ Designated as safety issue: No ]
  • Achieving a hemoglobin response by week 7 [ Time Frame: baseline to week 7 ] [ Designated as safety issue: No ]
  • Change in hemoglobin concentration from baseline to EOTP [ Time Frame: from baseline to EOTP ] [ Designated as safety issue: No ]
  • Time to first hematopoietic response [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Achieving a hemoglobin correction [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Number and percentage of subjects who exceed the hemoglobin concentration threshold [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 707
Study Start Date: January 2002
Study Completion Date: April 2004
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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
  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: NCT00038064

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00038064     History of Changes
Obsolete Identifiers: NCT00046982
Other Study ID Numbers: 20010101
Study First Received: May 28, 2002
Last Updated: September 11, 2008
Health Authority: Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement
Canada: Health Canada
Denmark: Laegemiddelstyrelsen
Finland: Lääkelaitos
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe
Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
Austria: Bundesamt für Sicherheit im Gesundheitswesen

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

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

ClinicalTrials.gov processed this record on July 23, 2014