Anemia in Patients With a Non-Myeloid Malignancy

NCT00038064 | Completed Phase 3

• 1 other identifier: 20010101
• Study Type: interventional
• Target: 707
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Neoplasms; Anemia

Keywords

anemia of cancer/chemotherapy; non-myeloid malignancies; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Time to first hemoglobin response during the treatment period

  during the treatment period

Secondary Outcomes (16)

• 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

Study Arms (2)

rHuEPO

ACTIVE COMPARATOR

Drug: rHuEPO

Darbepoetin alfa

EXPERIMENTAL

Drug: Darbepoetin alfa

Interventions

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.

Darbepoetin alfa

rHuEPO DRUG

150 IU/kg TIW

rHuEPO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

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

MeSH Terms

Conditions

Neoplasms; Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 28, 2002
• First Posted: May 29, 2002
• Study Start: January 1, 2002
• Primary Completion: October 1, 2003
• Study Completion: April 1, 2004
• Last Updated: September 15, 2008

Record last verified: 2008-09