An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation

Neoplasms Clinical Trial

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

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (PROCRIT®) administered 80,000 Units every three weeks in cancer patients that are not receiving chemotherapy or radiation therapy.

Clinical Trial Description

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 Design

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

Related Conditions & MeSH terms

• Anemia
• Neoplasms

• NCT number: NCT00210587
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Completed
• Phase: Phase 3
• Start date: February 2005
• Completion date: December 2005