Anemia in Patients With a Non-Myeloid Malignancy - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00038064

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Cancer

Drug Information available for: Erythropoietin Darbepoetin alfa

U.S. FDA Resources

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
rHuEPO: Active Comparator	Drug: rHuEPO 150 IU/kg TIW
Darbepoetin alfa: Experimental	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038064

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010101
Study First Received:	May 28, 2002
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00038064 History of Changes
Health Authority:	Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Canada: Health Canada; Denmark: Laegemiddelstyrelsen; Finland: Lääkelaitos; France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Hematinics
Hematologic Diseases
Darbepoetin alfa
Anemia

Additional relevant MeSH terms:

Neoplasms
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009