Status:
COMPLETED
Epoetin Alfa in Treating Patients With Anemia Who Are Undergoing Chemotherapy for Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anemia
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 epo...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00255749
Start Date
August 1 2005
Last Update
October 4 2012
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781