RATIONALE: Ro 50-3821 may stimulate red blood cell production and treat anemia in patients who are receiving antineoplastic therapy for non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: Primary * Compare the hemoglobin dose response of anemic patients with stage IIIB or IV non-small cell lung cancer receiving antineoplastic therapy treated with 6 different regimens of Ro 50-3821. Secondary * Compare the safety profile of these regimens in these patients. * Compare the pharmacokinetic profile of these regimens in these patients. * Determine additional pharmacodynamic characteristics of these regimens in these patients. OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are randomized to 1 of 6 treatment arms. In all arms, patients begin study therapy on the first day of a course of antineoplastic therapy. * Arm I: Patients receive a lower dose of Ro 50-3821 subcutaneously (SC) once weekly. * Arm II: Patients receive a medium dose of Ro 50-3821 SC once weekly. * Arm III: Patients receive a higher dose of Ro 50-3821 SC once weekly. * Arm IV: Patients receive a lower dose of Ro 50-3821 SC once every 3 weeks. * Arm V: Patients receive a medium dose of Ro 50-3821 SC once every 3 weeks. * Arm VI: Patients receive a higher dose of Ro 50-3821 SC once every 3 weeks. In all arms, treatment continues for 12 weeks in the absence of unacceptable toxicity. Patients are followed at 1 week. PROJECTED ACCRUAL: A total of 210 patients (35 per treatment arm) will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
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