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Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022386
First received: August 10, 2001
Last updated: July 17, 2013
Last verified: May 2002
  Purpose

RATIONALE: Epoetin alfa may stimulate red blood cell production to treat patients who have anemia following chemotherapy.

PURPOSE: Phase IV trial to study the effectiveness of epoetin alfa in treating chemotherapy-related anemia in women who have stage I, stage II, or stage III breast cancer.


Condition Intervention Phase
Anemia
Breast Cancer
Fatigue
Biological: epoetin alfa
Procedure: quality-of-life assessment
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care
Official Title: An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer

Resource links provided by NLM:


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

Study Completion Date: April 2004
Detailed Description:

OBJECTIVES: I. Determine the effectiveness and safety of epoetin alfa in patients receiving adjuvant chemotherapy for stage I, II, or III breast cancer. II. Determine the clinical outcomes in these patients receiving this drug.

OUTLINE: This is a multicenter study. Patients receive epoetin alfa subcutaneously once weekly for up to 24 weeks in the absence of unacceptable toxicity. Quality of life is assessed at baseline, at week 13, and at study completion.

PROJECTED ACCRUAL: A maximum of 2,500 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I, II, or III breast cancer Planned adjuvant anthracycline-based chemotherapy with or without a taxane for 3-6 months Hemoglobin 10-14 g/dL (independent of transfusion) No anemia due to factors other than cancer/chemotherapy (i.e., iron, cyanocobalamin, or folate deficiency; hemolysis; gastrointestinal bleeding; or myelodysplastic syndrome) Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 9 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled or severe cardiovascular disease No myocardial infarction within the past 6 months No uncontrolled hypertension No congestive heart failure Other: No hypersensitivity to mammalian cell-derived products No hypersensitivity to human albumin Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis- stimulating protein) No transfusion within the past 30 days No other concurrent epoetin alfa Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent treatments for anemia

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022386

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00022386     History of Changes
Other Study ID Numbers: ORTHO-PR-00-27-012, UCLA-0011004, CDR0000068811, ORTHO-PR-01-27-003, NCI-G01-2002
Study First Received: August 10, 2001
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
anemia
fatigue

Additional relevant MeSH terms:
Anemia
Breast Neoplasms
Fatigue
Breast Diseases
Hematologic Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014