Anemia in Patients With a Non-Myeloid Malignancy

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038064
• Other study ID #: 20010101
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2002
• Last updated: September 11, 2008
• Start date: January 2002
• Est. completion date: April 2004

Study information

• Verified date: September 2008
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et EnvironnementCanada: Health CanadaDenmark: LaegemiddelstyrelsenFinland: LääkelaitosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und ImpfstoffeNetherlands: Medisch Centrum Rijnmond_Zuid, lcatie ZuiderPortugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)Spain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationAustralia: Therapeutic Goods AdministrationAustria: Bundesamt für Sicherheit im Gesundheitswesen
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00046982

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: April 2004
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Neoplasms

Intervention

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.
• rHuEPO
150 IU/kg TIW

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

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

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling