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

NCT00246597 | Terminated Phase 3

• 1 other identifier: CR002305
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anemia; Breast Neoplasms; Hemoglobins; Quality of Life; Chemotherapy, Adjuvant

Keywords

Anemia; Breast cancer; Hemoglobin; Quality of Life; Adjuvant Chemotherapy; Pure red cell aplasia (PRCA); Cognitive and executive function

Outcome Measures

Primary Outcomes (1)

• To assess the effect of PROCRIT® on impairment of cognitive and executive function

Secondary Outcomes (1)

• 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.

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ortho Biotech Products, L.P.: lead

Related Links

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

MeSH Terms

Conditions

Anemia; Breast Neoplasms; Red-Cell Aplasia, Pure

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ortho Biotech Products, L.P. Clinical Trial

  Ortho Biotech Products, L.P.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: December 1, 2002
• Study Completion: June 1, 2004
• Last Updated: May 19, 2011

Record last verified: 2010-03