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A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy

Phase 3
18 Years
80 Years
Not Enrolling
Anemia, Multiple Myeloma, Lymphoma, Breast Cancer, Ovarian Cancer, Carcinoma, Small Cell Lung, Esophagus Cancer, Prostate Cancer, Neoplasm

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Trial Information

A Placebo-Controlled Study on the Effect of Epoetin Alfa in Patients With Malignancy Receiving Chemotherapy

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both.
Quality of life is also affected, in part because of the fatigue associated with anemia.
Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level
may improve quality of life and help patients live longer. This study is a 12-week,
double-blind, placebo-controlled multicenter study to compare the ability of epoetin alfa
and placebo in reducing or preventing anemia and transfusions, and to investigate
quality-of-life benefits associated with the use of epoetin alfa in patients receiving
chemotherapy for selected cancers. During the double-blind period there will be two groups
of patients: one group receiving epoetin injections under the skin 3 times per week
(starting at 150 units per kilogram, adjusted if needed to a maximum of 300 units per
kilogram) and other group receiving injections under the skin of a placebo of matching
appearance and volume. If hemoglobin rises above 140 grams per liter (women) or 150 grams
per liter (men), the dose will be adjusted to keep hemoglobin within a target range. A
12-week open-label extension of the study will be available to all patients completing the
12-week comparison period. The primary measure of effectiveness is determined by the
proportion of patients with no transfusions after the first month. Additional measures of
effectiveness include: the proportion of responders, the change of hemoglobin unrelated to
transfusion, cumulative transfusion rate and proportion of patients transfused during the
double-blind phase (excluding the first month), as well as the mean change over the study
period in scores for energy, activity and overall quality of life. The results will be
analyzed separately for non-platinum-containing chemotherapy and for different tumor types.
Safety evaluations include assessments of the incidence and severity of adverse events,
clinical laboratory tests, vital sign measurements, and physical examinations. The
hypothesis of the study is that epoetin alfa is superior to placebo in improving anemia,
reducing the number of transfusions, and improving quality of life. Epoetin alfa 150 units
(U) per kilogram (kg) or placebo, injected under the skin 3 times weekly for 4 weeks; then
either continued at 150 U/kg or adjusted to 300 U/kg according to hemoglobin levels for the
remaining 8 weeks. Open-label (12 weeks): dose to maintain target hemoglobin range.

Inclusion Criteria:

- Confirmed diagnosis of multiple myeloma, lymphoma, breast cancer, ovarian cancer,
small-cell lung cancer, esophagus cancer, or prostate cancer

- receiving treatment with chemotherapy, with at least 3 additional months of
chemotherapy planned

- a self-care performance score of 0 (fully active, no disease restriction) to 3
(capable of only limited self-care, confined to bed or chair more than 50% of waking

- life expectancy of at least 6 months

- baseline hemoglobin <12 grams per deciliter and baseline count of <100,000 microliter
for developing red cells

Exclusion Criteria:

- Clinically significant disease other than cancer

- evidence of uncontrolled hypertension or history of seizure

- transfusion within 1 week of the study

- radiotherapy within 2 weeks of study start

- use of corticosteroid or steroid drugs during the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients without transfusion after first month.

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.


United States: Institutional Review Board

Study ID:




Start Date:

February 1995

Completion Date:

May 1998

Related Keywords:

  • Anemia
  • Multiple Myeloma
  • Lymphoma
  • Breast Cancer
  • Ovarian Cancer
  • Carcinoma, Small Cell Lung
  • Esophagus Cancer
  • Prostate Cancer
  • Neoplasm
  • cancer
  • malignancy
  • red cell transfusion
  • epoetin alfa
  • epoetin
  • erythropoietin
  • red blood cells
  • Anemia
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Ovarian Neoplasms
  • Prostatic Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell
  • Esophageal Neoplasms