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

Condition(s) targeted: Anemia; Chemotherapy, Adjuvant; Hemoglobins; Quality of Life; Breast Neoplasms

Intervention: epoetin alfa (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Ortho Biotech Products, L.P.

Official(s) and/or principal investigator(s):
Ortho Biotech Products, L.P. Clinical Trial, Study Director, Affiliation: Ortho Biotech, Inc.

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.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To assess the effect of PROCRIT® on impairment of cognitive and executive function

Secondary outcome:

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.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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)

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

For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm

For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm

Starting date: December 2002
Ending date: June 2004
Last updated: February 6, 2008