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Epoetin Alfa in Treating Anemia in Patients Who Are Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003600
Recruitment Status : Completed
First Posted : February 20, 2004
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:

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

PURPOSE: Randomized double blinded phase III trial to compare the effectiveness of epoetin alfa with a placebo in treating anemia in cancer patients who are receiving chemotherapy.


Condition or disease Intervention/treatment Phase
Anemia Breast Cancer Chronic Myeloproliferative Disorders Drug/Agent Toxicity by Tissue/Organ Leukemia Lung Cancer Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Precancerous Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific Biological: epoetin alfa Other: placebo Phase 3

Detailed Description:

OBJECTIVES: I. Determine whether epoetin alfa treatment improves the quality of life in anemic patients who are undergoing chemotherapy for advanced malignancy. II. Determine whether epoetin alfa increases hemoglobin levels and decreases transfusion requirements in these patients. III. Validate or refute the use of an algorithm using pre- and posttreatment epoetin alfa, ferritin, and hemoglobin levels to predict 16 weeks response or no response to therapeutic doses of epoetin alfa as set forth by these patients. IV. Explore whether anemic patients receiving platinum-containing chemotherapy regimens experience less nephrotoxicity if they receive concurrent epoetin alfa compared to those who receive placebo.

OUTLINE: This is a randomized, double blind study. Patients are stratified by primary malignant disease (lung vs breast vs other), life expectancy (4-6 months vs greater than 6 months), planned concurrent radiotherapy (yes vs no), and degree of anemia (mild or at least 9 g/dL vs severe or less than 9 g/dL). Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks (arm I) or placebo subcutaneously once a week for a maximum of 16 weeks (arm II). Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase III Randomized Double-Blind Study of Erythropoietin Versus Placebo in Anemic Patients With Cancer Undergoing Chemotherapy
Study Start Date : December 1998
Actual Primary Completion Date : December 2001
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: epoetin alfa
Patients receiving chemotherapy are randomized to receive epoetin alfa subcutaneously once a week for a maximum of 16 weeks Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.
 Biological: epoetin alfa
Placebo Comparator: placebo
Patients receiving chemotherapy are randomized to receive placebo subcutaneously once a week for a maximum of 16 weeks. Quality of life is assessed at randomization and monthly throughout study. Patients are followed every 6 months for 1 year.
 Other: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Predict response [ Time Frame: Up to 12 months ]
  2. Response rate [ Time Frame: Up to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Anemic: Hemoglobin in males less than 11.5 g/dL; hemoglobin in females less than 10.0 g/dL No anemia secondary to B12, folic acid, or iron deficiency No anemia secondary to gastrointestinal bleed or hemolysis No anemia secondary to a primary or chemotherapy-induced myelodysplastic syndrome No anemia secondary to acute lymphocytic leukemia Histologically confirmed advanced malignancy Lung Breast Other Currently receiving myelosuppressive, cytotoxic chemotherapy for advanced cancer No patients receiving adjuvant therapy for cancer that has been surgically removed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 4 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension (systolic at least 180, diastolic at least 100) Other: Normal or elevated ferritin No known hypersensitivity to epoetin alfa Must be able to reliably take oral medication Must be alert and mentally competent Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 year since prior epoetin alfa At least 2 weeks since prior red blood cell transfusions No concurrent peripheral blood stem cell or bone marrow transplantation Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed Surgery: See Disease Characteristics

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003600


Locations
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Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Thomas E. Witzig, MD Mayo Clinic
More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003600    
Other Study ID Numbers: NCCTG-979253
CDR0000066673 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-P98-0133
First Posted: February 20, 2004    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Precancerous Conditions
Intestinal Neoplasms
Anemia
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Epoetin Alfa
Hematinics