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

Assessment of Early and Standard Intervention With Procrit® (Epoetin Alfa) 120,000 Units Once Every Three Weeks (Q3W) in Patients With Cancer Receiving Chemotherapy

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy.

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

OBJECTIVES:

Primary

• Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in patients with anemia undergoing chemotherapy for nonmyeloid cancer.
• Determine the safety of this drug in these patients.

Secondary

• Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I (early intervention): Patients receive epoetin alfa subcutaneously on day 1. Treatment repeats every 21 days for up to 5 courses.
• Arm II (standard intervention): Patients receive epoetin alfa as in arm I once their hemoglobin level is ≤ 10.5 g/dL.

Quality of life is assessed prior to start of study treatment, at week 7 during study treatment, and after completion of study treatment.

After completion of study treatment, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed nonmyeloid cancer

  • No history of myelodysplasia

• Baseline hemoglobin 11-12 g/dL

• No anemia due to factors other than cancer or chemotherapy (e.g., iron, cyanocobalamin [vitamin B_12], or folate deficiencies, hemolysis, or gastrointestinal bleeding)

• Receiving chemotherapy that meets the following criteria:

  • Administered weekly OR every 3 weeks
  • Must begin chemotherapy on or before the first day of study treatment

• No known, untreated CNS metastases

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• See Disease Characteristics
• Absolute neutrophil count ≥ 1,000/mm^3
• Platelet count ≥ 100,000/mm^3 (transfusion independent)
• Iron transferrin saturation > 20%
• No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)

Hepatic

• Bilirubin < 2.0 mg/dL
• SGPT ≤ 3 times upper limit of normal

Renal

• Creatinine ≤ 1.5 mg/dL
• No significant, uncontrolled genitourinary disease or dysfunction

Cardiovascular

• No uncontrolled cardiac arrhythmia in the past 6 months

• No uncontrolled hypertension

• No deep vein thrombosis, ischemic stroke, or other arterial or venous thrombotic events

  • Superficial thromboses allowed

• No other significant, uncontrolled cardiovascular disease or dysfunction

Pulmonary

• No significant, uncontrolled pulmonary disease or dysfunction
• No pulmonary emboli

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No infection requiring hospitalization or antibiotics in the past 14 days
• No known hypersensitivity to mammalian cell-derived products or to human albumin
• No new onset (in the past 3 months) poorly controlled seizures
• No other active malignancy except basal cell carcinoma or carcinoma in situ
• Not an employee of the investigator or study center or family members of the employee or the investigator
• No significant, uncontrolled neurological, endocrine, or gastrointestinal disease or dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Chemotherapy
• More than 3 months since prior erythropoietic agent (e.g., epoetin alfa, darbepoetin alfa, or gene-activated erythropoietin)
• More than 4 weeks since prior packed red blood cell transfusion
• No concurrent stem cell harvest of bone marrow
• No concurrent interleukin-11
• No other concurrent erythropoietic agent

Chemotherapy

• See Disease Characteristics
• No concurrent high-dose chemotherapy with stem cell transplantation

Radiotherapy

• No concurrent nonpalliative radiotherapy

Surgery

• More than 2 weeks since prior major surgery

Other

• At least 1 month since prior investigational agents or devices
• No concurrent high-dose IV iron supplementation