Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Anemia, Lung Cancer
About this trial
This is an interventional supportive care trial for Anemia focused on measuring anemia, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA