Epoetin Alfa in Treating Anemia in Patients With Solid Tumors - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058331

Purpose

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.

PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Supportive Care
Official Title:	A Phase III, Randomized Study Of Two Different Dosing Schedules Of Erythropoetin In Anemic Patients With Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

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

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

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

Study Start Date:	June 2003
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.
Compare the effects of these regimens on increasing hemoglobin levels in these patients.
Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild [hemoglobin at least 9.0 g/dL] vs severe [hemoglobin less than 9.0 g/dL]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder [including multiple myeloma] or lymphoproliferative disorder [including non-Hodgkin's lymphoma and chronic lymphocytic leukemia] vs all other neoplasms).

All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.

Arm I: Patients receive EPO SC once weekly for 18 weeks.
Arm II: Patients receive EPO SC on day 1 of weeks 4, 7, 10, 13, 16, and 19. Quality of life is assessed at randomization at then monthly during study treatment.

Patients are followed every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 330 patients (165 per treatment arm) will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)
Anemia secondary to cancer or cancer treatment*
- Hemoglobin less than 12 g/dL (males)
- Hemoglobin less than 11 g/dL (females) NOTE: *Active anticancer therapy is not required for study enrollment
Anemia must not be secondary to any of the following:
- B_12, folic acid, or iron deficiency
  - Ferritin must be normal or elevated
- Gastrointestinal bleeding or hemolysis
- Primary or chemotherapy-induced myelodysplastic syndromes
No untreated CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

At least 6 months

Hematopoietic

See Disease Characteristics

Hepatic

Not specified

Renal

Not specified

Cardiovascular

No history of uncontrolled cardiac arrhythmias
No history of deep venous thrombosis within the past year (unless on anticoagulation)
No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)

Pulmonary

No history of pulmonary embolism within the past year (unless on anticoagulation)

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after study participation
No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin
No new onset of seizures within the past 3 months
No poorly controlled seizures
Able and willing to complete quality of life forms
Alert and mentally competent to give informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

More than 6 months since prior epoetin alfa
More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)
No concurrent peripheral blood stem cell transplantation
No concurrent bone marrow transplantation

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

More than 14 days since prior major surgery

Other

More than 2 weeks since prior red blood cell transfusions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058331

Locations

United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

David P. Steensma, MD

Mayo Clinic

More Information

Additional Information:

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

Publications:

Steensma DP, Molina R, Sloan JA, Nikcevich DA, Schaefer PL, Rowland KM Jr, Dentchev T, Novotny PJ, Tschetter LK, Alberts SR, Hogan TF, Law A, Loprinzi CL. Phase III study of two different dosing schedules of erythropoietin in anemic patients with cancer. J Clin Oncol. 2006 Mar 1;24(7):1079-89.

Steensma DP, Molina R, Sloan JA, et al.: A phase III randomized trial of two different dosing schedules of erythropoietin (EPO) in patients with cancer-associated anemia: North Central Cancer Treatment Group (NCCTG) study N02C2. [Abstract] J Clin Oncol 23 (Suppl 16): A-8031, 736s, 2005.

ClinicalTrials.gov Identifier:	NCT00058331 History of Changes
Other Study ID Numbers:	CDR0000288821, NCCTG-N02C2
Study First Received:	April 7, 2003
Last Updated:	February 1, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

anemia
unspecified adult solid tumor, protocol specific
monoclonal gammopathy of undetermined significance
primary systemic amyloidosis
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia

stage IV chronic lymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
adult acute lymphoblastic leukemia in remission
untreated adult acute lymphoblastic leukemia
prolymphocytic leukemia
T-cell large granular lymphocyte leukemia
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
refractory hairy cell leukemia
untreated hairy cell leukemia
recurrent adult Hodgkin lymphoma
stage I adult Hodgkin lymphoma

Additional relevant MeSH terms:

Anemia
Neoplasms
Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Hematologic Diseases
Pathologic Processes
Neoplasms by Histologic Type

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012