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A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

This study has been terminated.
(Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling.)
Sponsor:
Information provided by:
Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:
NCT00246597
First received: October 28, 2005
Last updated: May 17, 2011
Last verified: March 2010
History of Changes
  Purpose

The purpose of this study is to determine whether it is possible to measure temporary difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for early stage breast cancer and to determine whether or not treatment with PROCRIT® will help decrease any problems with thinking or short-term memory that chemotherapy may cause.


Condition Intervention Phase
Anemia
Breast Neoplasms
Hemoglobins
Quality of Life
Chemotherapy, Adjuvant
 Drug: epoetin alfa
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ortho Biotech Products, L.P.:

Primary Outcome Measures:
  • To assess the effect of PROCRIT® on impairment of cognitive and executive function

Secondary Outcome Measures:
  • To assess the effect of PROCRIT® on severe fatigue, quality of life and mood. Hemoglobin (Hg) Responders were those patients who did not require transfusion during the treatment phase and who demonstrated a > or = 2 g/dL increase in Hg or Hg of 12 g/dL.

Enrollment: 37
Study Start Date: December 2002
Study Completion Date: June 2004
Detailed Description:

Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. The objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive PROCRIT versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL), and mood. Patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.

  Eligibility

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

Inclusion Criteria:

  • Histologic diagnosis of Stage I, II or III cancer (chemotherapy naïve for breast cancer) with anthracycline-based adjuvant chemotherapy with or without a taxane
  • Hemoglobin >=9 and <=14 g/dL unrelated to transfusion
  • Able to read, understand and complete QoL & Cognition tools
  • Patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment and use an adequate contraceptive method

Exclusion Criteria:

  • Patients who will receive more than a total of 24 weeks of chemotherapy
  • psychiatric or neurologic condition that would prevent informed consent and completion of questionnaires or that is poorly controlled with the current treatment regimen
  • severe hemiparesis or other condition, distal neuropathy, action tremor or other motor dysfunction, visual deficiencies preventing/decrease bimanual keyboard operation
  • severe bradyphrenia (slow thinking) or bradykinesia (slow movement)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246597

Sponsors and Collaborators
Ortho Biotech Products, L.P.
Investigators
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech Products, L.P.
  More Information

Additional Information:
A Phase III Clinical Trial of PROCRIT� (Epoetin alfa) versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00246597     History of Changes
Other Study ID Numbers: CR002305
Study First Received: October 28, 2005
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho Biotech Products, L.P.:
Anemia
Breast cancer
Hemoglobin
Quality of Life
 Adjuvant Chemotherapy
Pure red cell aplasia (PRCA)
Cognitive and executive function

Additional relevant MeSH terms:
Anemia
Breast Neoplasms
Neoplasms
Hematologic Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
 Epoetin Alfa
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013