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

Lung Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anemia
• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00072059
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: July 2003
• Completion date: February 2005