Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Darbepoetin alfa Compared With Epoetin alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI, Pharmaceutical / Industry	UCLA-0306021 AMGEN-20030125, NCT00070382

Objectives

Primary

1. Compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy.

Secondary

1. Compare the safety of these drugs in these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of a non-myeloid malignancy
  • The following diagnoses are excluded:
    • Acute myeloid leukemia
    • Chronic myeloid leukemia
    • Acute lymphoblastic leukemia
    • Hairy cell leukemia
    • Burkitt's lymphoma
    • Lymphoblastic lymphoma



• Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy



• Hemoglobin no greater than 11.0 g/dL



• No other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)

Prior/Concurrent Therapy:

Biologic therapy

• More than 30 days since prior darbepoetin alfa or epoetin alfa
• No other concurrent epoetin alfas

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 30 days since prior participation in investigational device or drug trials
• No prior randomization to this study
• No other concurrent investigational agents or procedures

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin less than 2 times upper limit of normal (ULN)

Renal

• Creatinine less than 2 times ULN

Cardiovascular

• No angina
• No congestive heart failure
• No New York Heart Association class III or IV heart disease
• No hypertension
• No cardiac arrhythmia
• No other unstable or uncontrolled disease or condition that would affect cardiac function

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No known seizure disorder
• No known sensitivity to study agents
• No clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)
• No confirmed neutralizing antibodies to epoetin alfa
• No other disorder that would preclude study compliance or giving informed consent

Expected Enrollment

A total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.

Outline

This is a randomized, open-label, multicenter study. Patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dL vs 10.0-11.0 g/dL) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive darbepoetin alfa subcutaneously (SC) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11).



• Arm II: Patients receive epoetin alfa SC once weekly for 12 weeks.

Patients are followed at 1 and 3 weeks .

Glaspy J, Vadhan-Raj S, Patel R, et al.: Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. J Clin Oncol 24 (15): 2290-7, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

John Glaspy, MD, MPH, Principal investigator		Ph: 310-794-4955; 888-798-0719

Registry Information
Official Title		A Randomized, Open-Label, Multicenter Study Of Darbepoetin Alfa Administered Once Every Two Weeks (Q2W) Compared With rHuEPO Administered Once Every Week (QW) For The Treatment Of Anemia In Subjects With Non-Myeloid Malignancies Receiving Multiple Chemotherapy
Trial Start Date		2003-08-20
Registered in ClinicalTrials.gov		NCT00070382
Date Submitted to PDQ		2003-09-02
Information Last Verified		2004-08-20
NCI Grant/Contract Number		P30-CA16042

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