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An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)

Phase 2
18 Years
Not Enrolling
Anemia, Chemotherapy

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Trial Information

An Open-Label Pilot Study to Evaluate the Effects of Alternate Dosing of PROCRIT� (Epoetin Alfa) in the Treatment of Patients With Cancer and Chemotherapy Induced Anemia (60,000 Units Weekly for Four Weeks Followed by 60,000 Units Every Two Weeks)

This was an open-label, non-randomized, multicenter pilot study where patients who were
receiving chemotherapy for non-myeloid malignancy (cancer) with a baseline hemoglobin (Hb)
<= 11 g/dL were enrolled. The primary objective of this pilot study was to estimate the
hematologic responses for the dosing regimen of PROCRIT (Epoetin alfa), starting at a dose
of 60,000 Units (U) administered subcutaneously (sc, under the skin) once per week (qw) for
four weeks ("Phase A"), followed by a dose of 60,000 U every two weeks (q2w) ("Phase B") in
patients with cancer and chemotherapy induced anemia. If, at any time during the study the
Hb level rose to >13 g/dL, PROCRIT (Epoetin alfa) therapy was held until the Hb reached <=12
g/dL, then resumed at a reduced dose in both Phase A and Phase B. The dose was also reduced
if a very rapid Hb response occurred (i.e. an increase of more than 1.3 g/dL in a 2-week
period). The secondary objective of the study was to determine the incidence of
anti-erythropoietin antibodies (anti-EPO Ab), at baseline and at end of study/early
withdrawal in patients who had received a minimum of one dose of PROCRIT (Epoetin alfa).
Rarely, anti-erythropoietin antibodies 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.

Safety evaluations included clinical laboratory tests (hemoglobin and hematocrit), vital
signs measurements (blood pressure), and incidence and severity of adverse events.

This study determined if higher initial weekly doses resulted in a higher initial response
rate and/or a more brisk hemoglobin rise. Patients received PROCRIT (Epoetin alfa) 60,000
Units (U) once a week for 4 weeks. At Week 5 if hemoglobin increased by >= 1 g/dL above
baseline, the PROCRIT dose was changed to 60,000 U every 2 weeks for <= 12 weeks. An
additional PROCRIT dose was given if chemotherapy completed before Week 16.

Inclusion Criteria:

- Histologically confirmed diagnosis of non-myeloid malignancy (no history of
myelodysplasia allowed) with a baseline hemoglobin of <= 11 g/dL, planned to receive
chemotherapy for a minimum of 12 weeks

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

- Negative serum pregnancy test at Screening and adequate contraceptive during
treatment and for three months after treatment

- Adequate hematologic function, adequate renal function and adequate hepatic function.

Exclusion Criteria:

- Planned radiation during the study

- Anemia due to factors other than cancer/chemotherapy (i.e., iron, B12 or folate
deficiencies, hemolysis or gastrointestinal bleeding)

- Prior treatment with Epoetin alfa or any other erythropoietic agent (e.g.,
Darbepoetin alfa) within the previous three months

- Significant, uncontrolled disease/dysfunction of the pulmonary, cardiovascular,
endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to
underlying malignancy or chemotherapy, uncontrolled hypertension or history of
uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis

- Transfusion of platelets or packed red blood cells within 28 days prior to the first
dose of study medication

- Planned stem cell harvest of bone marrow or high dose chemotherapy with stem cell
transplant during study duration.

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:

Proportion of patients with a >= 1 g/dL increase in Hb above baseline in Phase A independent of transfusion within 4 weeks

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:

August 2003

Completion Date:

April 2004

Related Keywords:

  • Anemia
  • Chemotherapy
  • Anemia
  • hemoglobin
  • chemotherapy
  • subcutaneous injection
  • Epoetin alfa
  • Anemia