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Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy


Phase 4
18 Years
N/A
Not Enrolling
Both
Anemia, Neoplasms

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Trial Information

Randomised Study to Evaluate the Effect of Early Intervention to Treat Anemia With Epoetin Alfa Versus Standard Use on Hemoglobin Levels and the Incidence of Blood Transfusions in Cancer Patients Receiving Chemotherapy


Cancer patients often experience anemia due to the disease itself, chemotherapy, or both.
Quality of life is also affected, due in part to the tiredness associated with anemia.
Previous studies with epoetin alfa have suggested that early intervention with epoetin alfa
results in higher hemoglobin levels and lower incidence of red blood cell transfusions than
are achieved with delayed intervention. This is a randomized, open-label, explorative,
sequential study that evaluates the effects of early treatment with epoetin alfa to
determine its impact on hemoglobin values and the need for red blood cell transfusions as
well as the safety of epoetin alfa when used in the prevention of anemia during chemotherapy
in adult patients with cancer. During their current course of chemotherapy, patients will
receive either early treatment with epoetin alfa or standard treatment with epoetin alfa
(epoetin alfa administered when hemoglobin is <=10 g/dL), in addition to best standard care.
Best standard care during chemotherapy may include red blood cell transfusions, white cell
growth factors, folic acid, and iron supplementation, as needed. Effectiveness will be
determined by the number of patients who receive an allogenic blood transfusion during the
study and the change in hemoglobin at 3 or 4 weeks, 8 or 9 weeks, and 12 weeks, and at the
end of the treatment period. Safety evaluations (incidence of adverse events, abnormal
clinical laboratory tests, and vital signs) will be performed throughout the study. The
study hypothesis is that cancer patients receiving chemotherapy who receive early treatment
with epoetin alfa will have higher hemoglobin levels and fewer red blood cell transfusions
than cancer patients receiving chemotherapy who receive standard treatment with epoetin
alfa. This study will be conducted in the Netherlands and will only enroll European patients
and will be generally well-tolerated. Epoetin alfa injections (40,000 units) under skin once
a week either within 7 days after start of first chemotherapy cycle or from day hemoglobin
is <=10 g/dL. Patients will receive epoetin alfa during the current course of chemotherapy
or up to 24 weeks. Dose may be adjusted.


Inclusion Criteria:



- Confirmed diagnosis of cancer and planned to receive chemotherapy in 1, 2, 3, or 4
weekly schedules for a minimum of 8 weeks

- have a hemoglobin level of >10 grams per deciliter and <= 12 grams per deciliter
within 14 days before the start of the first on-study chemotherapy cycle

- Eastern Cooperative Oncology Group (scale used by researchers to represent the level
of activity a patient is capable of) score of 0 (able to carry out all normal
activity without restriction) to 2 (ambulatory and capable of all self-care but
unable to carry out any work)

- life expectancy of >=6 months

- female subjects postmenopausal for at least 1 year, surgically sterile or practicing
an effective method of birth control

Exclusion Criteria:

- Clinically significant or uncontrolled disease/dysfunction of any body system that is
not due to cancer or chemotherapy, including uncontrolled or severe cardiovascular
disease, recent (< 6 months) myocardial infarction, uncontrolled high blood pressure,
congestive heart failure, or uncontrolled or unexplained history of seizures

- planned surgery expected to influence hemoglobin levels, within the first 8 or 9
weeks of study entry

- major illness or infection within 1 month of study entry

- highly increased risk of thrombotic or other vascular events

- androgen therapy within 2 months of study entry

- anemia due to factors other than cancer/chemotherapy (e.g., severe hemolysis,
gastrointestinal bleeding, or myelodysplastic syndromes)

- blood transfusion within 14 days prior to study entry

- pregnant or lactating females

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in hemoglobin from the start of the study to 3 or 4, 8 or 9, and 12 weeks, and at the end of the treatment period

Principal Investigator

Janssen-Cilag B.V. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen-Cilag B.V.

Authority:

Netherlands: Netherlands Medicines Evaluation Board

Study ID:

CR003541

NCT ID:

NCT00216541

Start Date:

August 2003

Completion Date:

September 2006

Related Keywords:

  • Anemia
  • Neoplasms
  • Anemia
  • cancer
  • transfusion
  • chemotherapy
  • hemoglobin
  • standard care
  • epoetin alfa
  • epoetin
  • erythropoietin
  • Anemia
  • Neoplasms

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