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Double-Blind, Placebo-Controlled Study to Assess the Effect of Early Intervention and/or Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing Chemotherapy

Phase 3
18 Years
Not Enrolling
Anemia, Cancer, Neoplasm

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Trial Information

Double-Blind, Placebo-Controlled Study to Assess the Effect of Early Intervention and/or Treatment With Epoetin Alfa on Anemia in Cancer Patients Receiving Non-Platinum-Containing 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 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 is a randomized,
double-blind, placebo-controlled, multicenter study to assess the effect of treatment with
epoetin alfa in reducing or preventing anemia and transfusions in patients receiving
non-platinum chemotherapy for non-myeloid cancers. The study also aims to determine whether
changes in erythropoietin and hemoglobin levels after 2 weeks, serum ferritin (iron) levels
after 2 weeks and changes in hemoglobin and developing red blood cells after either 2 or 4
weeks predict responsiveness to epoetin alfa. There will be 2 treatment groups: one group
will receive subcutaneous epoetin alfa injections 3 times per week (starting at 150 units
per kilogram, adjusted if needed to a maximum of 300 units per kilogram) and the other group
will receive an equal volume of matching subcutaneous placebo. Treatment is to continue for
12 to 24 weeks (3 to 6 chemotherapy cycles), plus 4 weeks post-chemotherapy. Patients in
the study will be observed a year after the study ends for survival data. The primary
measure of effectiveness will be determined by the number of patients who are transfused,
depending on primary tumor type (solid or blood) and level of hemoglobin (above or below
10.5 grams per deciliter). Additional measures of effectiveness include the change in
hemoglobin, hematocrit, and developing red blood cells from the start of the study until
study completion, and the change in quality of life. Safety evaluations (incidence and
severity of adverse events, laboratory tests, vital signs and physical examinations) will be
performed throughout the study. The hypothesis of the study is that epoetin alfa will be
superior to placebo in reducing the need for transfusions and in improving anemia and
quality of life. 150 units per kilogram of epoetin alfa (or placebo) 3 times weekly
subcutaneously for 4 weeks, then continuing this dose or 300 units per kilogram, depending
on developing red blood cell counts and/or hemoglobin. Study duration is 12 to 24 weeks (3
to 6 cycles) plus 4 weeks post-chemotherapy.

Inclusion Criteria:

- Confirmed diagnosis of non-myeloid malignancy

- undergoing treatment with non-platinum-containing chemotherapy, or
non-platinum-containing chemotherapy is imminent

- Eastern Cooperative Oncology Group (which is a scale used by researchers to represent
the level of activity that a patient is capable of) 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 hours)

- life expectancy of at least 6 months

- baseline hemoglobin <= 10.5 grams per deciliter (or a fall in hemoglobin level >= 1.5
grams per deciliter per cycle or per month since the beginning of the current course
of chemotherapy such that it dropped to <= 12 grams per deciliter) and baseline count
of <125,000 microliters for developing red cells

Exclusion Criteria:

- Patients having a clinically significant disease other than cancer

- treated by platinum-containing chemotherapy within 3 months of study start

- having uncontrolled high blood pressure, a history of seizure, or untreated iron,
folate, or Vitamin B12 deficiency

- received a transfusion or radiotherapy within 2 weeks of study start, or had surgery
within 1 week of study start

- intending to use 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 transfused after one 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:

August 1996

Completion Date:

September 1998

Related Keywords:

  • Anemia
  • Cancer
  • Neoplasm
  • Anemia
  • cancer
  • quality of life
  • chemotherapy
  • hemoglobin
  • transfusion
  • epoetin alfa
  • epoetin
  • erythropoietin
  • Anemia
  • Neoplasms