Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI, Other	CDR0000333213 UCLA-0306021, AMGEN-20030125, NCT00070382

Trial Description

Summary

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

Further Study Information

OBJECTIVES:

Primary

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

Secondary

• Compare the safety of these drugs in these patients.

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 .

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

Eligibility 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)

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Jonsson Comprehensive Cancer Center at UCLA

John A. Glaspy

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00070382
Information obtained from ClinicalTrials.gov on October 19, 2009

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