The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.

Condition	Treatment or Intervention	Phase
Anemia Cancer	Drug: Darbepoetin Alfa	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects with non-myeloid malignancies and anemia due to cancer
• > 18 years and of legal age for informed consent

Exclusion Criteria:

• Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
• Known history of seizure disorder
• Known history of cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction < 40%, or uncontrolled cardiac arrhythmia
• Uncontrolled hypertension
• Pregnant or breast feeding
• Concerns for subject's compliance with the protocol procedures

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Arizona
      Research Site, Tucson,  Arizona,  United States; Recruiting
California
      Research Site, Greenbrae,  California,  United States; Recruiting
      Research Site, Santa Monica,  California,  United States; Recruiting
Colorado
      Research Site, Thornton,  Colorado,  United States; Recruiting
Florida
      Research Site, Boynton Beach,  Florida,  United States; Recruiting
      Research Site, Coral Springs,  Florida,  United States; Recruiting
      Research Site, New Port Richey,  Florida,  United States; Recruiting
Indiana
      Research Site, Bloomington,  Indiana,  United States; Recruiting
      Research Site, Vincennes,  Indiana,  United States; Recruiting
Louisiana
      Research Site, Lafayette,  Louisiana,  United States; Recruiting
Minnesota
      Research Site, Minneapolis,  Minnesota,  United States; Recruiting
Missouri
      Research Site, St. Joseph,  Missouri,  United States; Recruiting
Montana
      Research Site, Great Falls,  Montana,  United States; Recruiting
Nevada
      Research Site, Las Vegas,  Nevada,  United States; Recruiting
New Hampshire
      Research Site, Hooksett,  New Hampshire,  United States; Recruiting
New Jersey
      Research Site, Summit,  New Jersey,  United States; Recruiting
North Carolina
      Research Site, Burlington,  North Carolina,  United States; Recruiting
      Research Site, Hickory,  North Carolina,  United States; Recruiting
North Dakota
      Research Site, Bismarck,  North Dakota,  United States; Recruiting
Ohio
      Research Site, Canton,  Ohio,  United States; Recruiting
      Research Site, Zanesville,  Ohio,  United States; Recruiting
South Carolina
      Research Site, Florence,  South Carolina,  United States; Recruiting
Texas
      Research Site, Richardson,  Texas,  United States; Recruiting
Washington
      Research Site, Tacoma,  Washington,  United States; Recruiting
      Research Site, Yakima,  Washington,  United States; Recruiting
Wisconsin
      Research Site, Brookfield,  Wisconsin,  United States; Recruiting
      Research Site, West Bend,  Wisconsin,  United States; Recruiting

Study ID Numbers:  20010103
Record last reviewed:  October 2004
Record first received:  September 17, 2004
ClinicalTrials.gov Identifier:  NCT00091858
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10