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.

Centocor Ortho Biotech

Status and phase

Terminated

Phase 3

Conditions

Anemia

Neoplasms

Treatments

Drug: Epoetin Alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00350090

CR005113

Details and patient eligibility

About

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.

Full 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.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
Female patients with reproductive potential must have a negative serum pregnancy test at screening.

Exclusion criteria

Uncontrolled hypertension
History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
Transfusion within 28 days prior to first dose
Planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months