Lymphoma Clinical Trial
Official title:
RC05CB A Pilot, Randomized Comparison of Standard Weekly Epoetin Alfa to Every-3-Week-Epoetin Alfa and Every 3-Week Darbepoetin Alfa
Verified date | October 2014 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 320 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hematopoietic response (hemoglobin rise of 2 g/dL from baseline OR achievement of hemoglobin within the goal range) | the proportion of patients who exhibit a hematopoietic response (defined as Hb rise >2 g/dL from baseline or achieving Hb = 11.5 g/dL, whichever occurs first, in the absence of RBC transfusions within 14 days of measurement) during the treatment period | 20 weeks | |
Secondary | Weekly change in hemoglobin levels | To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa | 16 weeks | No |
Secondary | Time required to achieve hemoglobin levels within the goal range | To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa | 16 weeks | No |
Secondary | Proportion of patients requiring red blood cell (RBC) transfusions and the number of transfusions required | To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa | 16 weeks | No |
Secondary | Dose reduction in each regimen | To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa | No | |
Secondary | Adverse events as measured by CTCAE v3.0 | To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa | 16 weeks | No |
Secondary | Quality of life as measured by Functional Assessment of Cancer Therapy Scales for Anemia, Linear Analogue Self Assessment measures, Brief Fatigue Inventory, and Symptom Distress Scale at baseline and at 4, 8, 16, and 24 weeks | To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa | 16 weeks | No |
Secondary | Mean hemoglobin increment week by week | To compare the effects of the 3 different epoetin alfa dosing schedules and an every-3-weeks darbepoetin alfa | 16 weeks | No |
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