NCT00060398已完成3 期
Study Of Epoetin Alfa Vs Epoetin Alfa With Dexamethasone In Hormone Refractory Prostate Cancer Patients: Impact On Fatigue, Anemia, Functional Status And Quality Of Life
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 280
- 主要终点
- Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale
研究概览
简要总结
RATIONALE: Epoetin alfa may stimulate red blood cell production and may help improve cancer-related anemia and fatigue. Steroid therapy with dexamethasone may increase the effectiveness of epoetin alfa. It is not yet known if epoetin alfa is more effective with or without dexamethasone in treating anemia-related fatigue in patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying epoetin alfa and dexamethasone to see how well they work compared to epoetin alfa alone in treating anemia-related fatigue in patients with prostate cancer that is refractory to treatment with hormone therapy.
详细描述
OBJECTIVES:
- Compare the effect of epoetin alfa with or without dexamethasone on the level of cancer-related fatigue measured by the FACIT fatigue subscale, in patients with hormone-refractory prostate cancer.
- Compare the effect of these regimens on increasing hemoglobin levels in these patients.
- Compare the effect of these regimens on palliation of other disease-related symptoms and on functional status and overall quality of life of these patients.
- Compare the survival rate of these regimens in these patients.
- Compare the toxicity profile of these regimens in these patients.
- Determine the incidence of adrenal suppression in these patients after receiving dexamethasone therapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to usual fatigue severity on the Brief Fatigue Inventory numerical scale (3-6 vs 7-10) and hemoglobin level (8-10 g/dL vs 10.1-11.9 g/dL). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive epoetin alfa subcutaneously once a week.
- Arm II: Patients receive epoetin alfa as in arm I and oral dexamethasone once a day.
In both arms, treatment continues for 12 weeks in the absence of unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed prostate cancer
- •Hormone-refractory disease as evidenced by progression on bone scan or CT scan with a rising prostate-specific antigen
- •Prior bilateral orchiectomy OR other primary hormonal therapy (e.g., estrogen therapy or luteinizing hormone-releasing hormone analog [LHRH] and flutamide) with evidence of treatment failure
- •Concurrent continual LHRH agonist therapy (e.g., depot leuprolide or goserelin) required for patients who have not undergone bilateral orchiectomy
- •Must have anemia with hemoglobin ≥ 8 g/dL and < 12 g/dL within the past 14 days
- •Must be iron replete (i.e., ferritin > 50 ng/mL) within the past 30 days
- •Presence of fatigue with usual fatigue severity ≥ 3 on the 0-10 numerical scale of the Brief Fatigue Inventory within the past 14 days
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •No disseminated intravascular coagulation
- •No autoimmune hemolytic anemia
- •AST and ALT ≤ 2 times upper limit of normal
- •No prior hemochromatosis or iron intolerance
- •Creatinine < 2.5 mg/dL
- •Cardiovascular
- •Adequate blood pressure (i.e., systolic blood pressure < 140 mm Hg and diastolic blood pressure < 90 mm Hg) (treated or untreated)
- •No history of thromboembolic events
- •No unstable angina
- •No poorly controlled cardiac disease
- •Fertile patients must use effective contraception
- •Able to read, understand, and answer questions on the symptom and quality of life study instruments
- •No ongoing chronic hemorrhage (e.g., gross hematuria due to advanced prostate cancer)* NOTE: *Microscopic hematuria allowed
- •No acute or subacute illness that may require transfusion
- •No gastrointestinal bleeding
- •No active systemic infection
- •No known or suspected hypersensitivity to human albumin
- •No known or suspected hypersensitivity to mammalian cell-derived products
- •No uncontrolled diabetes
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 30 days since prior epoetin alfa
- •Chemotherapy
- •More than 21 days since prior chemotherapy
- •No more than 2 different types of prior chemotherapy regimens for hormone-refractory prostate cancer
- •Endocrine therapy
- •See Disease Characteristics
- •More than 30 days since prior corticosteroids for hormone-refractory prostate cancer
- •Episodic use of low-dose steroids for other causes is allowed
- •Radiotherapy
- •More than 21 days since prior radiotherapy
- •Concurrent radiotherapy allowed
- •See Disease Characteristics
- •More than 8 weeks since prior blood transfusion
- •No concurrent oral or intravenous antibiotics
排除标准
- 未提供
结局指标
主要结局
Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale
次要结局
- Survival at 6 months
- Adrenal suppression
- Toxicity
- Anemia response at 3 months
- Functional level as measured by the Functional Assessment of Cancer Therapy-General Scale and Brief Fatigue Inventory functional interference score monthly
- Symptom distress as measured by the Memorial Symptom Assessment Scale-Short Form and the number of symptoms monthly
- Quality of life as measured by the Functional Assessment of Cancer Therapy-General Scale monthly
研究者
研究点 (280)
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