NCT00072059

Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia
• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	methoxy polyethylene glycol epoetin beta

Timeline

• Start date: 2003-07-01
• Completion: 2005-02-01
• First posted: 2003-11-06
• Last updated: 2013-07-18

Locations

1 site across 1 country: United States