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The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Chemotherapy

Phase 2
18 Years
Not Enrolling
Anemia, Neoplasms

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Trial Information

The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Chemotherapy

Patients undergoing treatment with adriamycin-containing chemotherapy frequently develop
significant anemia. Agents that can increase the amount of hemoglobin in cancer patients
undergoing treatment with non-platinum-containing cyclic chemotherapy may improve the
patients' reduced physical strength and reduced stamina resulting from anemia, improve the
patients' ability to continue chemotherapy, and improve the patients' overall qualify of
life. Epoetin alfa is a genetically engineered form of a natural hormone, erythropoietin,
that is used to treat anemia by stimulating red blood cell production. This is a
randomized, double-blind, placebo-controlled, parallel group, multicenter study. The study
evaluates the safety and effectiveness of epoetin alfa in treating patients who develop
persistent anemia as a result of treatment with aggressive non-platinum-containing cyclic
chemotherapy for any cancer type (except rapid and severe onset of leukemias and
malignancies of the bone marrow and spleen). The study consists of a screening period when
patients' eligibility is determined, a 12-week double-blind treatment period when patients
receive 3 injections each week with either epoetin alfa or placebo, and an optional
open-label treatment period when patients who choose to continue will receive 3 injections
of epoetin alfa per week during any remaining cycles of their chemotherapy. Eligible
patients will be randomly assigned to one of two treatment groups: one group receiving
epoetin alfa 150 units/kilogram and the other group receiving a comparable volume of
placebo. Study drug is administered by injection beneath the skin 3 times weekly for 12
weeks. The dose of study medication may be increased or decreased at the discretion of the
physician, based on the results of blood tests. Depending on the patient's chemotherapy
cycle, he or she will return to the study site every 3 or 4 weeks for administration of
study medication. Safety evaluations (laboratory tests, vital sign measurements, reporting
of adverse events, physical examination, and electrocardiogram) are performed throughout the
study. The primary measures of effectiveness of the study drug will be determined by the
number of transfusions patients require and by changes in blood test results for hemoglobin,
hematocrit, and reticulocytes (immature red blood cells) from before the start of the study
to the end of the study. The study hypothesis is that epoetin alfa will, more effectively
than placebo, stimulate adequate production of red blood cells to increase the hemoglobin
level in cancer patients who are anemic as a result of undergoing treatment with aggressive
non-platinum-containing cyclic chemotherapy. Double-blind: Epoetin alfa 150 units/kilogram
(U/kg) or matching volume placebo injected beneath the skin 3 times weekly for 12 weeks.
Open-label: Epoetin alfa at the dose received at the end of the double-blind study injected
beneath the skin 3 times weekly for any remaining cycles of chemotherapy.

Inclusion Criteria:

- Patients with cancer (except for rapid onset of severe leukemia and malignancies of
the bone marrow and spleen) and anemia resulting from non-cisplatin-containing
chemotherapy who are receiving cyclic chemotherapy for <=5 consecutive days every 3
or 4 weeks (for 3 cycles of chemotherapy)

- having a Performance score of 0, 1, 2, or 3 (patients' ability to perform daily
activities, 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 hours])

- having a life expectancy of at least 3 months

- with signs and symptoms of physical stability for 1 month before the study, (based on
physical examination including vital signs, weight, and electrocardiogram), not
grossly obese, and having a hemoglobin <= 10.5 grams/deciliter (g/dL)

- who are able to demonstrate the ability to administer self-injections

Exclusion Criteria:

- Patients with a history of any blood disease

- having signs and symptoms of significant disease/dysfunction not caused by the
underlying cancer

- having a spread of cancer to the brain

- having uncontrolled high blood pressure, an iron, folate or vitamin B12 deficiency,
or a history of seizures

- received therapy with androgen within 2 months before the start of study, received
radiation therapy or surgery to decrease the number of cancer cells within 30 days
before the start of the study, or experienced sudden and severe onset of illness
within 7 days before the start of 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:

Number of transfusions; Change from baseline in levels of hemoglobin, hematocrit, reticulocytes (immature red blood cells)

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: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

June 1990

Related Keywords:

  • Anemia
  • Neoplasms
  • Anemia
  • chemotherapy
  • epoetin alfa
  • epogen
  • erythropoietin
  • neoplasms
  • cancer
  • Anemia
  • Neoplasms