Darbepoetin Alfa Compared With Epoetin Alfa in Treating Anemia in Patients Receiving Chemotherapy for Cancer - Full Text View

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00070382

Purpose

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.

Condition	Intervention	Phase
Anemia Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Precancerous/Nonmalignant Condition Unspecified Adult Solid Tumor, Protocol Specific	Biological: darbepoetin alfa Biological: epoetin alfa	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control
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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia transthyretin amyloidosis

MedlinePlus related topics: Anemia Cancer Fungal Infections Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma

Drug Information available for: Erythropoietin Epoetin alfa Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2003

Detailed Description:

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00070382

Locations

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

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

John A. Glaspy, MD, MPH

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000333213, UCLA-0306021, AMGEN-20030125
Study First Received:	October 3, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00070382 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

anemia
unspecified adult solid tumor, protocol specific
Waldenstrom macroglobulinemia
monoclonal gammopathy of undetermined significance
extramedullary plasmacytoma
isolated plasmacytoma of bone
refractory multiple myeloma
primary systemic amyloidosis
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
post-transplant lymphoproliferative disorder
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma

stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent adult T-cell leukemia/lymphoma
stage I adult T-cell leukemia/lymphoma
stage II adult T-cell leukemia/lymphoma
stage III adult T-cell leukemia/lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:

Epoetin Alfa
Precancerous Conditions
Blood Protein Disorders
Hematologic Agents
Paraproteinemias
Hemostatic Disorders
Leukemia
Pathologic Processes
Hemorrhagic Disorders
Therapeutic Uses
Lymphoma, Large-Cell, Immunoblastic
Cardiovascular Diseases
Lymphoma
Disease
Neoplasms by Histologic Type

Immunoproliferative Disorders
Immune System Diseases
Hematinics
Hematologic Diseases
Anemia
Vascular Diseases
Darbepoetin alfa
Pharmacologic Actions
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on February 08, 2010