RATIONALE: Darbepoetin alfa and epoetin alfa may stimulate red blood cell production to treat patients who have anemia and are receiving chemotherapy. It is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating anemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.

Condition	Treatment or Intervention	Phase
Fatigue Anemia unspecified adult solid tumor, protocol specific	Drug: darbepoetin alfa  Drug: epoetin alfa  Procedure: fatigue assessment/management  Procedure: hematologic toxicity attenuation  Procedure: supportive care/therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare the time to hemoglobin response in patients with non-myeloid malignancies receiving chemotherapy and darbepoetin alfa vs epoetin alfa.
• Compare the percentage of patients achieving hemoglobin response by week 7 when treated with these regimens.
• Compare the change in FACT-Fatigue scale score by week 7 in patients treated with these regimens.
• Compare the overall adverse event profiles of these regimens, including incidence of negative clinical consequences (e.g., hypertension, thrombosis) and formation of neutralizing antibodies in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to baseline hemoglobin concentration (less than 10 g/dL vs 10-11.0 g/dL) and country. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive darbepoetin alfa subcutaneously (SC) once weekly beginning on day 1 of chemotherapy and continuing until hemoglobin concentration reaches at least 12.0 g/dL or for the duration of treatment. Patients then receive darbepoetin alfa SC every 3 weeks. Treatment continues for up to 16 weeks.
• Arm II: Patients receive epoetin alfa SC three times a week beginning on day 1 of chemotherapy and continuing for up to 16 weeks. Fatigue is assessed at baseline and then weekly for 17 weeks.

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: Approximately 1,200 patients (600 per treatment arm) will be accrued for this study within 1 year.

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

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of non-myeloid malignancy
• Must be scheduled to receive multicourse cytotoxic chemotherapy for at least 12 weeks
• Cancer and/or chemotherapy-associated anemia
• Hemoglobin no greater than 11.0 g/dL
• No other primary hematological disorder that would cause anemia (e.g., sickle cell anemia)

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal

• Creatinine no greater than 2 times ULN

Cardiovascular

• No unstable or uncontrolled disease or condition related to or affecting cardiac function
• No unstable angina
• No congestive heart failure
• No New York Heart Association class III or IV heart disease
• No uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg)
• No cardiac arrhythmia

Other

• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No seizure disorder
• No chronic infection
• No significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
• No neutralizing antibodies to epoetin alfa
• No hypersensitivity to any recombinant mammalian-derived product

PRIOR CONCURRENT THERAPY: Biologic therapy

• At least 2 weeks since prior RBC transfusions
• At least 4 weeks since prior epoetin alfa or darbepoetin alfa
• No more than 2 RBC transfusions within 4 weeks before study
• No other concurrent epoetins

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 30 days since prior investigational drugs or devices
• No prior participation in this study
• No other concurrent investigational drugs

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095,  United States

Study chairs or principal investigators

John A. Glaspy, MD, MPH,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000257197; UCLA-0201098; NCI-G02-2112; AMGEN-200101101
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  October 3, 2002
ClinicalTrials.gov Identifier:  NCT00046982
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08