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A Pilot Study to Evaluate the Hematologic Response Rate of PROCRIT� (Epoetin Alfa) at 80,000 Units Once Weekly in Anemic Cancer Patients Receiving Chemotherapy

Phase 3
18 Years
Not Enrolling
Anemia, Cancer, Chemotherapy

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Trial Information

A Pilot Study to Evaluate the Hematologic Response Rate of PROCRIT� (Epoetin Alfa) at 80,000 Units Once Weekly in Anemic Cancer Patients Receiving Chemotherapy

When comparing the proposed study dose to current literature, the initial study dose of
80,000 Units administered once per week is equivalent to an individual dose of 1142 Units/kg
body weight for a 70 kg patient. It is also common in clinical practice for anemic cancer
patients to be treated with a dose of PROCRIT (Epoetin alfa) of 40,000 Units weekly. This
study was an open-label, non-randomized pilot study of cancer patients with non-myeloid
malignancies with a hemoglobin < = 11 g/dL planned to receive at least 12 weeks of
chemotherapy. The objective of the study was to evaluate the hematologic response, safety,
and clinical outcomes of PROCRIT (Epoetin alfa) at 80,000 Units given subcutaneously (under
the skin) once weekly in anemic cancer patients receiving chemotherapy. If, at any time the
hemoglobin was > 13 g/dL, PROCRIT (Epoetin alfa) therapy was held until the hemoglobin was
<= 12 g/dL, then resumed at 60,000 Units once weekly. The dose was also reduced if the
hemoglobin rose by > 1.3 g/dL in a 2 week period.

Additionally, the incidence of anti-erythropoietin antibodies at baseline and at end of
study/early withdrawal in study patients who have received a minimum of two or more doses of
PROCRIT (Epoetin alfa) over at least a one-month period was evaluated. Rarely, antibodies to
erythropoietin may form in patients who have some types of diseases (e.g., autoimmune
diseases, rheumatoid arthritis, anemia of chronic disease) or in response to exposure to
erythropoietin products such as Epoetin alfa necessitating discontinuation of the
erythropoietin agent and medical treatment that may include blood transfusions. Hemoglobin
level, vital signs (blood pressure) and occurrence and severity of adverse events was
assessed throughout the study. PROCRIT (Epoetin alfa) was given at a dose of 80,000 Units
subcutaneously (under the skin) for 12 weeks. The PROCRIT (Epoetin alfa) dose was monitored
throughout the study and the dose was withheld or reduced as necessary to maintain
hemoglobin level and rate of hemoglobin rise.

Inclusion Criteria:

- Patients with a confirmed diagnosis of any non-myeloid malignancy planned to have
received at least 12 weeks of chemotherapy with hemoglobin <= 11 g/dL

- Life expectancy > 6 months with Eastern Cooperative Oncology Group (ECOG) Performance
Status 0-2

- Both male and female patients with reproductive potential must have used an adequate
contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives,
barrier device with spermicide or surgical sterilization) during treatment and for
three months after completing treatment. Female patients with reproductive potential
had a negative serum pregnancy test within 7 days of the first dose of study drug.

Exclusion Criteria:

- Previous radiation therapy to > 25% bone marrow reserve or planned radiation during
study duration

- Packed red blood cells (PRBC) transfusion within 28 days of study entry

- Anemia due to factors other than cancer/chemotherapy, i.e., iron, folate, Vitamin B12
deficiency, hemolysis or GI bleeding

- Previous treatment with Epoetin alfa or any investigational forms of erythropoietin
(e.g., gene-activated erythropoietin, novel erythropoiesis stimulating protein)
within the previous 3 months

- uncontrolled hypertension or history of thrombotic vascular events

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint was major response defined as the proportion of patients with >= 2 g/dL hemoglobin (Hb) increase from baseline or Hb >= 12 g/dL and independent of transfusion within 28 days.

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:

June 2003

Completion Date:

May 2004

Related Keywords:

  • Anemia
  • Cancer
  • Chemotherapy
  • Anemia
  • Hemoglobin
  • Chemotherapy
  • Epoetin alfa
  • Anemia