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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Anemia
• Intervention / Treatment: Drug: rHuEPO; Drug: Darbepoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 707
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first hemoglobin response during the treatment period	during the treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall incidence of adverse events, serious adverse events, and severe or life threatening adverse events	throughout study
Incidence, if any, of neutralizing antibody formation to study drug (darbepoetin alfa or rHuEPO)	throughout study
Average weekly dosage of study drug during the 16-week treatment period	16-week treatment period
Receiving red blood cell (RBC) transfusion from week 5 to week 12	from week 5 to week 12
Change in FACT-Fatigue scale score from baseline to week 7	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	throughout study
Profile of change in FACT-Fatigue scale score from baseline over the treatment period	from baseline over the treatment period
Change in FACT-Fatigue scale score from baseline to End of Treatment Period (EOTP)	from baseline to EOTP
Change in FACT-Physical Well-being scale score from baseline to EOTP	from baseline to EOTP
Receiving RBC transfusion during the treatment period	during the treatment period
Number of units of RBC transfused during the treatment period	during the treatment period
Achieving a hemoglobin response by week 7	baseline to week 7
Change in hemoglobin concentration from baseline to EOTP	from baseline to EOTP
Time to first hematopoietic response	throughout study
Achieving a hemoglobin correction	throughout study
Number and percentage of subjects who exceed the hemoglobin concentration threshold	throughout study

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• FDA-approved Drug Labeling
• To access clinical trial results information click on this link

Study record dates

Study Major Dates

• Study Start: January 1, 2002
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: May 28, 2002
• First Submitted That Met QC Criteria: May 28, 2002
• First Posted (Estimate): May 29, 2002

Study Record Updates

• Last Update Posted (Estimate): September 15, 2008
• Last Update Submitted That Met QC Criteria: September 11, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Drug Therapy; anemia of cancer/chemotherapy; non-myeloid malignancies
• Additional Relevant MeSH Terms: Hematologic Diseases; Neoplasms; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: 20010101