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

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 3

Conditions: Anemia; Multiple Myeloma and Plasma Cell Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific; Lymphoproliferative Disorder; Precancerous/Nonmalignant Condition; Lymphoma; Leukemia

Treatments: Drug: darbepoetin alfa; Drug: epoetin alfa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00070382

UCLA-0306021

CDR0000333213

AMGEN-20030125

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Primary

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

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of a non-myeloid malignancy
• Currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy
• Hemoglobin no greater than 11.0 g/dL
• 18 and over
• ECOG 0-2
• Bilirubin less than 2 times upper limit of normal (ULN)
• Creatinine less than 2 times ULN
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• More than 30 days since prior darbepoetin alfa or epoetin alfa
• More than 30 days since prior participation in investigational device or drug trials

Exclusion criteria

• The following diagnoses are excluded:

  • Acute myeloid leukemia
  • Chronic myeloid leukemia
  • Acute lymphoblastic leukemia
  • Hairy cell leukemia
  • Burkitt's lymphoma
  • Lymphoblastic lymphoma

• other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia)

• angina

• congestive heart failure

• New York Heart Association class III or IV heart disease

• hypertension

• cardiac arrhythmia

• other unstable or uncontrolled disease or condition that would affect cardiac function

• pregnant or nursing

• known seizure disorder

• known sensitivity to study agents

• clinically significant inflammatory disease (e.g., rheumatoid arthritis or Crohn's disease)

• confirmed neutralizing antibodies to epoetin alfa

• other disorder that would preclude study compliance or giving informed consent

• other concurrent epoetin alfas

• prior randomization to this study

• other concurrent investigational agents or procedures

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Darbepoetin alfa

Experimental group

Description:

darbepoetin alfa administered once every two weeks at a dose of 200 ug over a 16 week treatment period.

Treatment:

Drug: darbepoetin alfa

Epoetin alfa

Active Comparator group

Description:

epoetin alfa administered at 40,000 unites, once per week over a 16-week treatment period.

Treatment:

Drug: epoetin alfa