A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.

Last updated: May 17, 2011
Sponsor: Ortho Biotech Products, L.P.
Overall Status: Terminated

Phase

3

Condition

Anemia

Neoplasms

Treatment

N/A

Clinical Study ID

NCT00350090
CR005113
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly 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 less than or equal to 11 g/dL unrelated to transfusion

  • Patients must not be receiving or planning to receive chemotherapy or radiotherapywithin the 16-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.

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: 98
Study Start date:
September 01, 2002
Estimated Completion Date:
March 31, 2004

Study Description

This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy of PROCRIT (Epoetin alfa) with regard to hematopoietic response when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic patients with cancer not receiving chemotherapy or radiation therapy. Hematological laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence and severity of adverse events will be assessed throughout the study. Patients will receive a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin level.