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

2014-08-27 03:54:47 | BioPortfolio

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.

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, Control: Active Control, Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Anemia

Intervention

methoxy polyethylene glycol epoetin beta

Location

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles
California
United States
90095-1781

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:47-0400

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