A Pilot Study To Evaluate The Response Rate Of Procrit (Epoetin Alfa) At 60,000 Units Every Two Weeks In Anemic Patients With Cancer Not Receiving Chemotherapy Or Radiation Therapy
Inclusion 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