Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00072059


Primary Contact:

Principal Investigator
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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