Status:
COMPLETED
Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anemia
Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Epoetin alfa and darbepoetin alfa may cause the body to make more red blood cells. They are used to treat anemia caused by chemotherapy in patients with cancer. PURPOSE: This randomized cl...
Detailed Description
OBJECTIVES: Primary * Compare the relative efficacy of four different erythropoietic agent dosing schedules comprising epoetin alfa or darbepoetin alfa, in terms of the proportion of patients with c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of solid tumor or nonmyeloid hematologic malignancy (e.g., plasma cell dyscrasia or lymphoproliferative disorder)
- No nonmelanomatous skin cancer
- Hemoglobin ≤ 10.5 g/dL
- Ferritin \> 20 ng/mL (i.e., not obviously iron deficient)
- Planning to receive ≥ 12 weeks of anticancer chemotherapy
- Biological therapy (e.g., hypomethylating agents, monoclonal antibodies, or small molecule pathway inhibitors) with an individual or cumulative regimen incidence of grade 3 or 4 anemia \> 10% is considered chemotherapy for purposes of this study
- No known anemia secondary to any of the following:
- Cyanocobalamin (vitamin B\_12) or folic acid deficiency
- Gastrointestinal bleeding within the past 2 weeks
- Hemolysis
- Myelodysplastic syndromes, myeloproliferative disorders, or acute myeloid leukemia
- No primary hematologic disorder causing chronic moderate to severe anemia (e.g., congenital dyserythropoietic anemia, homozygous hemoglobin S disease or compound heterozygous sickling states, or thalassemia major)
- Carriers of these disease states allowed provided they are not anemic prior to cancer diagnosis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- Not pregnant or nursing
- No delivery of a baby of ≥ 18 weeks estimated gestational age within the past 3 months (90 days)
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight \> 40.0 kg and \< 150.0 kg
- No known hypersensitivity to epoetin alfa, darbepoetin alfa, mammalian-cell derived products, or human albumin
- No uncontrolled hypertension, defined as systolic blood pressure (BP) ≥ 180 mm Hg and/or diastolic BP ≥ 100 mm Hg, despite medical therapy
- No pulmonary emboli and/or deep vein thrombosis within the past 12 months
- Patients actively receiving warfarin for a minimum of 4 weeks are exempted from this requirement
- Prior superficial thrombophlebitis allowed
- No cerebrovascular accident, ischemic stroke, acute coronary syndrome (e.g., unstable angina or Q-wave or non-Q wave myocardial infarction), or other arterial or venous thrombotic events within the past 6 months
- No history of chronic hypercoagulable disorders (e.g., activated protein C resistance, anti-cardiolipin disorder, protein C deficiency, or protein S deficiency)
- Patients receiving anticoagulation therapy (warfarin or acetylsalicyclic acid \[aspirin\] at a dose of ≥ 325 mg/day) for these conditions are eligible provided therapy is continued during the study period
- History of previously treated seizures allowed provided the patient has been seizure-free for a minimum of 3 months
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 1 year since prior peripheral blood stem cell, bone marrow, or cord blood transplantation
- More than 14 days since prior red blood cell transfusion
- More than 14 days since prior major surgery, including, but not limited to, any of the following:
- Amputation
- Invasion of a body cavity or of the central nervous system using a scalpel, saw, or laser cutting tool
- Resection of a body part (or parts), whether solid or liquid tissue or both, that includes ≥ 1% of a patient's preoperative weight
- The following are not considered major surgery:
- Diagnostic/therapeutic thoracentesis or paracentesis
- Diagnostic skin biopsy
- Digit or fingernail/thumbnail resection or laceration repair under local anesthesia
- Diagnostic fat aspiration
- Otic irrigation to remove cerumen impaction
- Tympanocentesis
- Uncomplicated dental extraction
- Uncomplicated tonsillectomy
- Laser corneal remodeling for refraction purposes
- Cosmetic or therapeutic eyelid surgery
- Bone marrow aspiration and biopsy
- More than 10 weeks since prior darbepoetin alfa, epoetin alfa, or any investigational form of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis stimulating protein)
- No planned stem cell transplantation within the next 4 months (18 weeks)
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT00416624
Start Date
May 1 2007
End Date
June 1 2009
Last Update
February 10 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905