An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (PROCRITÂ®) administered 80,000 Units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy.
|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 Response Rate of Epoetin Alfa (PROCRIT) at 80,000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy|
- Percent of patients that achieved a hematopoietic response, defined as a Hb increase >= 2 g/dL and/or Hb = 12 g/dL during the study independent of transfusion within 28 days
- Transfusion requirements, change in Quality of Life scores measured by LASA & FACT-An, mean time to hematopoietic response (defined in Primary Endpoint) & mean time to >= 1g/dL change in Hb from baseline. Incidence of adverse events for study duration
|Study Start Date:||February 2005|
|Study Completion Date:||December 2005|
The current approved dosage for epoetin alfa is 40,000 Units once per week with an escalation to 60,000 Units once per week if the response is inadequate after four weeks of treatment at 40,000 Units. This dosing scheme, while proven to be efficacious, is often inconvenient for both patients and medical personnel. This is an open-label, non-randomized, multi-center pilot study with the objective to investigate the efficacy of epoetin alfa (PROCRIT®) with regard to hematopoietic response when administered at 80,000 Units subcutaneously every three weeks in anemic patients with cancer not receiving chemotherapy or radiation therapy. Patients will receive two epoetin alfa injections (40,000 Units per injection) under the skin once every three weeks for a maximum of 13 weeks, totalling a maximum of four treatments. Doses may be reduced depending on the patients' hemoglobin level.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|