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AnemiaPhase 3NCT00246597

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

A Phase 3 study testing epoetin alfa in people with Anemia and Breast Neoplasms, run by Ortho Biotech Products, L.P..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Anemia, Breast Neoplasms, Hemoglobins
What is being tested?
epoetin alfa
How many people
37 participants
Where
No sites listed yet
Study dates
Dec 2002to Jun 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

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.

Read the 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.

Being tested
epoetin alfa
Keywords
Anemia, Breast cancer, Hemoglobin, Quality of Life, Adjuvant Chemotherapy, Pure red cell aplasia (PRCA), Cognitive and executive function
Medical subject headings
Anemia, Breast Neoplasms, Red-Cell Aplasia, Pure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epoetin alfaDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2005 (estimated)
  2. Study startDec 2002
  3. Study completionJun 2004

Why it stopped: Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00246597
Sponsor's protocol ID
CR002305
Status last verified
Mar 2010
First submitted
28 Oct 2005
Last updated
19 May 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing epoetin alfa in people with Anemia and Breast Neoplasms, run by Ortho Biotech Products, L.P..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the effect of PROCRIT® on impairment of cognitive and executive function. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00246597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.

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