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

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.

Eligibility Criteria:
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