An Open Label, Randomized, Multicenter, Phase II Study To Determine Hemoglobin Dose Response, Safety And Pharmacokinetic Profile Of Ro 50-3821 Given Subcutaneously Once Weekly Or Once Every 3 Weeks To Anemic Patients With Stage IIIB or IV Non-Small Cell Lung Carcinoma Receiving Antineoplastic Therapy

Date de début de l'étude : 1 juillet 2003

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Stage IIIB or IV * Currently receiving first- or second-line antineoplastic therapy (must be scheduled to receive therapy during the 12 weeks of study therapy) * Antineoplastic therapy may include single agent or combination chemotherapy, corticosteroids, or a combination of these agents * Hemoglobin no greater than 11 g/dL * Transfusion independent * No known primary or metastatic CNS malignancy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * See Disease Characteristics * Platelet count 50,000-500,000/mm\^3 * No functional iron deficiency\* (e.g., transferrin saturation less than 20% OR serum ferritin less than 100 ng/mL) * No known hemolysis NOTE: \*Concurrent iron supplementation to correct deficiency allowed Hepatic * Not specified Renal * Creatinine no greater than 2.5 mg/dL Cardiovascular * No clinically significant hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix * No acute or chronic bleeding requiring therapy within the past 3 months (e.g., patients with anemia caused by gastrointestinal bleeding) * No known cyanocobalamin deficiency * No known folic acid deficiency * No acute infection or inflammatory disease (C-reactive protein greater than 50 mg/L) * No known resistance to epoetin administration * No newly diagnosed (i.e., within the past 6 months) or uncontrolled epilepsy PRIOR CONCURRENT THERAPY: Biologic therapy * More than 8 weeks since prior recombinant human erythropoietin therapy or any other erythropoiesis-stimulating drugs Chemotherapy * See Disease Characteristics Endocrine therapy * See Disease Characteristics Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 4 weeks since prior red blood cell transfusion * More than 30 days since prior investigational drugs or regimens * No prior enrollment and randomization to this study * No other concurrent investigational drugs or regimens