Epoetin Alfa in Treating Anemia in Patients With Solid Tumors

RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with solid tumors. It is not yet known whether epoetin alfa given once a week is more effective than epoetin alfa given once every 3 weeks in treating anemia.

PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have solid tumors.

OBJECTIVES:

* Compare the effects of 2 different schedules of epoetin alfa on decreasing transfusion requirements in anemic patients with nonmyeloid cancer.
* Compare the effects of these regimens on increasing hemoglobin levels in these patients.
* Compare the effects of these regimens on overall quality of life (QOL) and anemia-specific components of QOL in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent chemotherapy or radiotherapy (yes vs no), concurrent platinum-based (cisplatin or carboplatin) chemotherapy (yes vs no), degree of anemia (mild \[hemoglobin at least 9.0 g/dL\] vs severe \[hemoglobin less than 9.0 g/dL\]), age (60 and under vs over 60), and type of neoplasm (plasma cell disorder \[including multiple myeloma\] or lymphoproliferative disorder \[including non-Hodgkin's lymphoma and chronic lymphocytic leukemia\] vs all other neoplasms).

All patients receive epoetin alfa (EPO) subcutaneously (SC) once weekly for 3 weeks. Patients are then randomized to 1 of 2 treatment arms.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a nonmyeloid cancer (excluding nonmelanoma skin cancer)
* Anemia secondary to cancer or cancer treatment\*

  * Hemoglobin less than 12 g/dL (males)
  * Hemoglobin less than 11 g/dL (females) NOTE: \*Active anticancer therapy is not required for study enrollment
* Anemia must not be secondary to any of the following:

  * B_12, folic acid, or iron deficiency

    * Ferritin must be normal or elevated
  * Gastrointestinal bleeding or hemolysis
  * Primary or chemotherapy-induced myelodysplastic syndromes
* No untreated CNS metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* At least 6 months

Cardiovascular

* No history of uncontrolled cardiac arrhythmias
* No history of deep venous thrombosis within the past year (unless on anticoagulation)
* No uncontrolled hypertension (systolic blood pressure at least 180 mm Hg and diastolic blood pressure at least 100 mm Hg) within the past year (unless on anticoagulation)

Pulmonary

* No history of pulmonary embolism within the past year (unless on anticoagulation)

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No known hypersensitivity to epoetin alfa, mammalian cell-derived products, or human albumin
* No new onset of seizures within the past 3 months
* No poorly controlled seizures
* Able and willing to complete quality of life forms
* Alert and mentally competent to give informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 6 months since prior epoetin alfa
* More than 6 months since any prior investigational forms of epoetin alfa (e.g., gene-activated epoetin alfa or novel erythropoiesis-stimulating protein)
* No concurrent peripheral blood stem cell transplantation
* No concurrent bone marrow transplantation

Surgery

* More than 14 days since prior major surgery

Other

* More than 2 weeks since prior red blood cell transfusions