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

Last updated: June 8, 2011
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Overall Status: Completed

Phase

3

Condition

Neoplasms

Anemia

Treatment

N/A

Clinical Study ID

NCT00210587
CR003223
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of non-myeloid malignancy

  • Baseline hemoglobin value of <= 11 g/dL unrelated to transfusion

  • Patients must not be receiving or planning to receive chemotherapy or radiotherapywithin the 13-week study period. However, patients receiving hormonal therapy ornon-myelosuppressive therapies are allowable

  • Female patients with reproductive potential must have a negative serum pregnancy testat screening

  • Patients must have signed an informed consent

Exclusion

Exclusion Criteria:

  • Uncontrolled hypertension

  • History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonaryemboli, deep vein thrombosis, ischemic stroke, other arterial or venous thromboticevents (excluding superficial thromboses), or known history of chronic coagulationdisorder

  • Transfusion within 28 days prior to first dose

  • Planned chemotherapy or radiation during study and no prior chemotherapy within 8weeks or radiation within 4 weeks of study entry

  • No prior treatment with Epoetin alfa or any other erythropoietic agent within theprevious two months

Study Design

Total Participants: 51
Study Start date:
February 01, 2005
Estimated Completion Date:
December 31, 2005

Study 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.