RATIONALE: Epoetin alfa may stimulate red blood cell production and treat anemia in patients with non-myeloid cancer.

PURPOSE: Clinical trial to study the effectiveness of epoetin alfa in treating cancer-related anemia in patients with non-myeloid cancer who are not currently receiving chemotherapy or radiation therapy.

Condition	Treatment or Intervention
adult solid tumor Anemia Leukemia Lymphoma plasma cell neoplasm	Drug: epoetin alfa  Procedure: complications of therapy assessment/management  Procedure: hematologic toxicity attenuation  Procedure: supportive care/therapy

OBJECTIVES: Primary

• Determine the efficacy of epoetin alfa, in terms of hematologic response, in patients with non-myeloid malignancy and cancer-related anemia who are not currently receiving chemotherapy or radiotherapy.

Secondary

• Determine time to hematologic response in patients treated with this drug.
• Determine transfusion requirements in patients treated with this drug.
• Determine the safety and tolerability of this drug in these patients.
• Determine the quality of life of patients treated with this drug.

OUTLINE: This is an open-label, nonrandomized, pilot, multicenter study.

Patients receive epoetin alfa subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then at weeks 5, 9, 13, and 17.

Patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed non-myeloid malignancy
• Cancer-related anemia (hemoglobin ≤ 11 g/dL for males OR ≤ 10 g/dL for females) AND meets one of the following criteria:
• Post adjuvant chemotherapy
• Post radiotherapy
• Metastatic disease and post chemotherapy or not receiving chemotherapy
• Receiving hormonal therapy or androgen-deprivation therapy
• Receiving immunotherapy (i.e., interleukin-2 or interferon) or non-myelosuppressive therapy, including any of the following:
• Monoclonal antibody infusions
• Antiangiogenesis inhibitors
• Signal transduction inhibitors
• No prior cancer therapy
• No anemia due to factors other than cancer or chemotherapy (e.g., iron, B_12, or folate deficiencies; hemolysis; or gastrointestinal bleeding)
• No history of myelodysplasia
• No untreated CNS metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 4 months

Hematopoietic

• See Disease Characteristics
• Absolute neutrophil count ≥ 1,000/mm^3*
• Platelet count ≥ 100,000/mm^3* NOTE: *No transfusion within 28 days of obtaining lab values

Hepatic

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

Renal

• Creatinine ≤ 1.5 mg/dL

Cardiovascular

• No uncontrolled hypertension
• No uncontrolled cardiac arrhythmia within the past 6 months
• No clinically significant, uncontrolled cardiovascular disease or dysfunction not attributable to underlying malignancy or chemotherapy
• No thrombosis within the past 6 months

Pulmonary

• No clinically significant, uncontrolled pulmonary disease or dysfunction not attributable to underlying malignancy or chemotherapy
• No pulmonary embolism within the past 6 months

Neurologic

• No clinically significant, uncontrolled neurologic disease or dysfunction not attributable to underlying malignancy or chemotherapy
• No new-onset (within the past 3 months) or poorly controlled seizures

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation
• No major infection requiring hospitalization and antibiotics within the past 2 weeks
• No known hypersensitivity to mammalian cell-derived products or human albumin
• No clinically significant, uncontrolled endocrine, genitourinary, or gastrointestinal disease or dysfunction not attributable to underlying malignancy or chemotherapy
• No other active malignancy except basal cell carcinoma in situ

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• More than 2 months since prior epoetin alfa or any other erythropoietic agents (e.g., darbepoetin alfa or gene-activated erythropoietin)
• No concurrent interleukin-11
• No concurrent stem cell harvest of bone marrow
• No concurrent high-dose chemotherapy with stem cell transplantation
• No other concurrent erythropoietic agents

Chemotherapy

• See Disease Characteristics
• See Biologic therapy
• More than 8 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• More than 4 weeks since prior radiotherapy
• No prior radiotherapy to > 25% of bone marrow reserve
• No concurrent radiotherapy

Surgery

• More than 14 days since prior major surgery

Other

• More than 28 days since prior platelet or packed red blood cell transfusion
• More than 30 days since prior experimental drugs or devices
• No other concurrent experimental drugs
• No other concurrent anti-anemia medications

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-6996,  United States; Recruiting

Study chairs or principal investigators

John A. Glaspy, MD, MPH,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000380849; UCLA-040304801; ORTHO-PR03-27-002
Record last reviewed:  August 2004
Record first received:  September 7, 2004
ClinicalTrials.gov Identifier:  NCT00090935
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-18