NCT00072059已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status
- •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
- •Not specified
- •Creatinine no greater than 2.5 mg/dL
- •Cardiovascular
- •No clinically significant hypertension
- •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
- •Not specified
- •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
排除标准
- 未提供
研究者
研究点 (2)
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