darbepoetin alfa compared with epoetin alfa in treating anemia in patients receiving chemotherapy for cancer

Conditions: Anemia; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Precancerous/Nonmalignant Condition; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: darbepoetin alfa and epoetin alfa may stimulate red blood cell production and treat anemia in patients who are receiving chemotherapy. it is not yet known whether darbepoetin alfa is more effective than epoetin alfa in treating patients with anemia. purpose: randomized phase iii trial to compare the effectiveness of darbepoetin alfa with that of epoetin alfa in treating anemia in patients who are receiving chemotherapy for cancer.

objectives: primary * compare the efficacy of darbepoetin alfa vs epoetin alfa for anemia in patients with non-myeloid malignancies receiving chemotherapy. outline: this is a randomized, open-label, multicenter study. patients are stratified according to screening hemoglobin concentration (less than 10.0 g/dl vs 10.0-11.0 g/dl) and type of concurrent chemotherapy (platinum-based vs non-platinum-based). patients are randomized to 1 of 2 treatment arms. * arm i: patients receive darbepoetin alfa subcutaneously (sc) every other week for 12 weeks (i.e., on weeks 1, 3, 5, 7, 9, and 11). * arm ii: patients receive epoetin alfa sc once weekly for 12 weeks. patients are followed at 1 and 3 weeks . projected accrual: a total of 600 patients (300 per treatment arm) will be accrued for this study within 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of a non-myeloid malignancy * currently receiving or planning to receive at least 8 weeks of cyclic cytotoxic chemotherapy * hemoglobin no greater than 11.0 g/dl * 18 and over * ecog 0-2 * bilirubin less than 2 times upper limit of normal (uln) * creatinine less than 2 times uln * negative pregnancy test * fertile patients must use effective contraception * hiv negative * more than 30 days since prior darbepoetin alfa or epoetin alfa * more than 30 days since prior participation in investigational device or drug trials exclusion criteria: * the following diagnoses are excluded: * acute myeloid leukemia * chronic myeloid leukemia * acute lymphoblastic leukemia * hairy cell leukemia * burkitt's lymphoma * lymphoblastic lymphoma * other primary hematologic disorder that would cause anemia (e.g., sickle cell anemia) * angina * congestive heart failure * new york heart association class iii or iv heart disease * hypertension * cardiac arrhythmia * other unstable or uncontrolled disease or condition that would affect cardiac function * pregnant or nursing * known seizure disorder * known sensitivity to study agents * clinically significant inflammatory disease (e.g., rheumatoid arthritis or crohn's disease) * confirmed neutralizing antibodies to epoetin alfa * other disorder that would preclude study compliance or giving informed consent * other concurrent epoetin alfas * prior randomization to this study * other concurrent investigational agents or procedures

Keywords: anemia unspecified adult solid tumor, protocol specific waldenstrom macroglobulinemia monoclonal gammopathy of undetermined significance extramedullary plasmacytoma isolated plasmacytoma of bone refractory multiple myeloma primary systemic amyloidosis stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma post-transplant lymphoproliferative disorder angioimmunoblastic t-cell lymphoma anaplastic large cell lymphoma stage i cutaneous t-cell non-hodgkin lymphoma stage ii cutaneous t-cell non-hodgkin lymphoma stage iii cutaneous t-cell non-hodgkin lymphoma stage iv cutaneous t-cell non-hodgkin lymphoma recurrent adult t-cell leukemia/lymphoma stage i adult t-cell leukemia/lymphoma stage ii adult t-cell leukemia/lymphoma stage iii adult t-cell leukemia/lymphoma stage iv adult t-cell leukemia/lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma recurrent mycosis fungoides/sezary syndrome stage i mycosis fungoides/sezary syndrome stage ii mycosis fungoides/sezary syndrome stage iii mycosis fungoides/sezary syndrome stage iv mycosis fungoides/sezary syndrome recurrent adult hodgkin lymphoma stage i adult hodgkin lymphoma stage ii adult hodgkin lymphoma stage iii adult hodgkin lymphoma stage iv adult hodgkin lymphoma t-cell large granular lymphocyte leukemia refractory chronic lymphocytic leukemia stage 0 chronic lymphocytic leukemia stage i chronic lymphocytic leukemia stage ii chronic lymphocytic leukemia stage iii chronic lymphocytic leukemia stage iv chronic lymphocytic leukemia prolymphocytic leukemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage i grade 1 follicular lymphoma stage i grade 2 follicular lymphoma stage i grade 3 follicular lymphoma stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iii grade 3 follicular lymphoma stage iv grade 1 follicular lymphoma stage iv grade 2 follicular lymphoma stage iv grade 3 follicular lymphoma contiguous stage ii adult diffuse large cell lymphoma contiguous stage ii adult diffuse mixed cell lymphoma contiguous stage ii adult diffuse small cleaved cell lymphoma noncontiguous stage ii adult diffuse large cell lymphoma noncontiguous stage ii adult diffuse mixed cell lymphoma noncontiguous stage ii adult diffuse small cleaved cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma stage i adult diffuse large cell lymphoma stage i adult diffuse mixed cell lymphoma stage i adult diffuse small cleaved cell lymphoma stage iii adult diffuse large cell lymphoma stage iii adult diffuse mixed cell lymphoma stage iii adult diffuse small cleaved cell lymphoma stage iv adult diffuse large cell lymphoma stage iv adult diffuse mixed cell lymphoma stage iv adult diffuse small cleaved cell lymphoma contiguous stage ii adult immunoblastic large cell lymphoma noncontiguous stage ii adult immunoblastic large cell lymphoma recurrent adult immunoblastic large cell lymphoma stage i adult immunoblastic large cell lymphoma stage iii adult immunoblastic large cell lymphoma stage iv adult immunoblastic large cell lymphoma contiguous stage ii mantle cell lymphoma noncontiguous stage ii mantle cell lymphoma recurrent mantle cell lymphoma stage i mantle cell lymphoma stage iii mantle cell lymphoma stage iv mantle cell lymphoma contiguous stage ii grade 1 follicular lymphoma contiguous stage ii grade 2 follicular lymphoma contiguous stage ii grade 3 follicular lymphoma noncontiguous stage ii grade 1 follicular lymphoma noncontiguous stage ii grade 2 follicular lymphoma noncontiguous stage ii grade 3 follicular lymphoma