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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.
- 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.
- 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.
Allocation: Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Supportive Care
methoxy polyethylene glycol epoetin beta
Jonsson Comprehensive Cancer Center, UCLA
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:54:47-0400
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