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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anemia, Lung Cancer

Intervention / Treatment
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* Biological: methoxy polyethylene glycol epoetin beta


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IIIB or IV Currently receiving first- or second-line antineoplastic therapy (must be scheduled to receive therapy during the 12 weeks of study therapy) Antineoplastic therapy may include single agent or combination chemotherapy, corticosteroids, or a combination of these agents Hemoglobin no greater than 11 g/dL Transfusion independent No known primary or metastatic CNS malignancy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic See Disease Characteristics Platelet count 50,000-500,000/mm^3 No functional iron deficiency* (e.g., transferrin saturation less than 20% OR serum ferritin less than 100 ng/mL) No known hemolysis NOTE: *Concurrent iron supplementation to correct deficiency allowed Hepatic Not specified Renal Creatinine no greater than 2.5 mg/dL Cardiovascular No clinically significant hypertension Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix No acute or chronic bleeding requiring therapy within the past 3 months (e.g., patients with anemia caused by gastrointestinal bleeding) No known cyanocobalamin deficiency No known folic acid deficiency No acute infection or inflammatory disease (C-reactive protein greater than 50 mg/L) No known resistance to epoetin administration No newly diagnosed (i.e., within the past 6 months) or uncontrolled epilepsy PRIOR CONCURRENT THERAPY: Biologic therapy More than 8 weeks since prior recombinant human erythropoietin therapy or any other erythropoiesis-stimulating drugs Chemotherapy See Disease Characteristics Endocrine therapy See Disease Characteristics Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 4 weeks since prior red blood cell transfusion More than 30 days since prior investigational drugs or regimens No prior enrollment and randomization to this study No other concurrent investigational drugs or regimens

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: methoxy polyethylene glycol epoetin beta|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer