A Study to Evaluate the Hematologic Response Rate (the Rate at Which the Hemoglobin Level Rises) of PROCRIT (Epoetin Alfa) Given at a Dose of 80,000 Units Once Weekly to Cancer Patients With Anemia Who Are Receiving Chemotherapy.
The purpose of this study is to evaluate the hematologic response, safety, and clinical outcomes of PROCRIT administered once a week in anemic cancer patients receiving chemotherapy.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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.
- The secondary efficacy endpoint was minor response defined as the proportion of patients with >= 1 g/dL hemoglobin (Hb) increase from baseline (up to 1.9 g/dL increase) and incidence of transfusion and independent of transfusion within 28 days.
|Study Start Date:||June 2003|
|Study Completion Date:||May 2004|
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.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|