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Chrysarobin

Epoetin Alfa

methoxy polyethylene glycol epoetin beta

John A. Glaspy, MD, MPH

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.

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.

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

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer	NCT00072059	Anemia Lung Cancer	methoxy polyeth...	18 Years -	National Cancer Institute (NCI)
Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer	NCT00072059	Anemia Lung Cancer	methoxy polyeth...	18 Years -	National Cancer Institute (NCI)
Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer	NCT00072059	Anemia Lung Cancer	methoxy polyeth...	18 Years -	National Cancer Institute (NCI)

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