PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 2

Conditions

Anemia

Neoplasms

Treatments

Drug: Epoetin Alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00388336

CR004594

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy.

Full description

This was an open-label (doctors and patients knew which drug was being administered), non-randomized (patients were assigned to treatment), multi-center pilot study with the objective to investigate the effectiveness of PROCRIT (Epoetin alfa) on hematopoietic response (effect on red blood cells) when administered at 60,000 Units subcutaneously (under the skin) every two weeks in anemic patients with cancer who were not receiving chemotherapy or radiation therapy.

Treatment with study drug was for a maximum of 12 weeks followed by a 4-week observation period after the last dose of the study drug had been administered.

Safety and efficacy evaluations were performed at specified intervals throughout the study and included assessment of laboratory tests (Complete Blood Count [CBC], Serum Chemistry [including hemoglobin level]), vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events. All patients enrolled in this study received pharmacologic ferrous sulfate 325 mg by mouth once a day or an equivalent formulation, as tolerated, unless it was determined by the physician that the patient should not receive it. All patient's received injections of PROCRIT (Epoetin alfa) 60,000 Units under the skin once every two weeks. If after 4 weeks of treatment, the patient's hemoglobin level did not increase by >= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units every 2 weeks. Study drug was administered for a maximum of 12 weeks followed by a 4-week observation period after the last dose of study drug. Epoetin alfa doses were reduced or held as needed depending on the patients' hemoglobin level.

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must have 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 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

Patients must not have uncontrolled hypertension or a history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
No transfusion within 28 days prior to first dose
No 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.