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

NCT ID: NCT00070382

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Darbepoetin alfa

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

Group Type: EXPERIMENTAL

darbepoetin alfa

Intervention Type: DRUG

darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period

Epoetin alfa

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

Group Type: ACTIVE_COMPARATOR

epoetin alfa

Intervention Type: DRUG

epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period

Interventions

darbepoetin alfa

darbepoetin alfa administered at a dose of 200ug once every 2 weeks over a 16-week treatment period

Intervention Type: DRUG

epoetin alfa

epoetin alfa administered at a dose of 40,000U once every week over a 16-week treatment period

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A. Glaspy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Countries

United States

References

20030125 Study Group Trial; Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. 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. 2006 May 20;24(15):2290-7. doi: 10.1200/JCO.2005.03.8570.

Reference Type: RESULT

PMID: 16710026 (View on PubMed)

Other Identifiers

UCLA-0306021

Identifier Type: -

Identifier Source: secondary_id

AMGEN-20030125

Identifier Type: -

Identifier Source: secondary_id

CDR0000333213

Identifier Type: -

Identifier Source: org_study_id