Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00072059|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Anemia Lung Cancer||Biological: methoxy polyethylene glycol epoetin beta||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||July 2003|
|Actual Study Completion Date :||February 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072059
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||John A. Glaspy, MD, MPH||Jonsson Comprehensive Cancer Center|