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
- 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
- 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
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
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|