Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- AnemiaLung Cancer
- Registration Number
- NCT00072059
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States