Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 clinical trial is studying four different schedules of epoetin alfa or darbepoetin alfa to compare how well they work in treating patients with anemia caused by chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Darbepoetin alfa; Epoetin Alfa

Criteria

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)