Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia.

PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Collaborator: Ortho Biotech, Inc.
• Treatments: Epoetin Alfa

Criteria

ELIGIBILITY CRITERIA

• 18 years of age or greater

• Must have Hb less than 11 g/dl and normal hematopoesis

• Must have non-myeloid malignancies treated with myelosuppressive therapy *Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Must have a life expectancy of 6 months or greater

• Must have adequate liver function (bilirubin less than or equal to 2.0 mg) and renal function (creatinine less than or equal to 2.0 mg)

• Must have normal serum folate and vitamin B12 levels or be receiving replacement therapy

• Must be iron replete (transferring saturation great than or equal to 20 percent and ferritin greater than or equal to 100 mg/ml) or be receiving replacement therapy

• Must be able to fully comprehend and give written consent.

• Female patients with reproductive potential must be practicing an effective method of birth control (e.g., abstinence, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, surgical sterilization) before entry and throughout the study.

• Female patients with reproductive potential must have a negative serum human chorionic gonadotropin (HCG) pregnancy test at screening (within 7 days before the first dose of study drug)

Exclusion criteria

• Patient has uncontrolled hypertension

• Patient has history of symptomatic cardiac disease

• Patient has serious intercurrent illness

• The patient is pregnant, has a positive serum HCG or is lactating Patient has known hypersensitivity to mammalian cell-derived products or human albumin.

• Patient has diagnosis of polycythemia vera, chronic myelogenous leukemia, myelodysplastic syndrome

• May not be due for transplant within 24 weeks

• Anemia due to factors other than cancer.

• History of a thrombotic vascular event.

• History of seizures

• Patient has received a red blood cell growth factor (epoetin alfa or darbepoetin) within the last 60 days