NCT00110123终止3 期
Intravenous Versus Intra-Arterial Fotemustine Chemotherapy in Patients With Liver Metastases From Uveal Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
European Organisation for Research and Treatment of Cancer - EORTC16 个研究点 分布在 4 个国家目标入组 171 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 171
- 试验地点
- 16
- 主要终点
- Duration of survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different ways may kill more tumor cells. It is not yet known whether giving fotemustine as an intravenous infusion is more effective than giving it as a hepatic arterial infusion in treating liver metastases.
PURPOSE: This randomized phase III trial is studying intravenous infusion of fotemustine to see how well it works compared to hepatic arterial infusion of fotemustine in treating patients with unresectable liver metastases from eye melanoma.
详细描述
OBJECTIVES:
Primary
- Compare overall survival of patients with surgically incurable or unresectable liver metastases secondary to uveal melanoma treated with fotemustine administered as an intravenous infusion vs an intra-arterial hepatic perfusion.
Secondary
- Compare progression-free survival of patients treated with this drug.
- Compare the response rate in patients treated with this drug.
- Compare the duration of objective response in patients treated with this drug.
- Compare the patterns of progression in patients treated with this drug.
- Compare treatment-related toxic effects and catheter-related complications in patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 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 liver metastases secondary to uveal melanoma
- •Surgically incurable or unresectable disease
- •No detectable extrahepatic metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •ALT and AST < 5 times ULN
- •Alkaline phosphatase < 5 times ULN
- •Gamma-glutamyltransferase < 5 times ULN
- •Lactic dehydrogenase < 5 times ULN
- •BUN < 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No uncontrolled angina pectoris
- •No myocardial infarction within the past 6 months
- •No uncontrolled high blood pressure
- •No evolutive intracranial hypertension
- •No other severe cardiac disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active gastroduodenal ulcer
- •No diabetes
- •No active or uncontrolled infection
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •No other uncontrolled severe medical condition
- •No other malignancy within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunologic or biologic therapy
- •Chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy for metastatic disease
- •No concurrent radiotherapy
- •Recovered from prior major surgery
- •No prior antineoplastic drugs for metastatic disease
- •More than 4 weeks since prior investigational drugs
- •No other concurrent anticancer agents or therapies
排除标准
- 未提供
结局指标
主要结局
Duration of survival
次要结局
- Progression-free survival
- Best response as assessed by RECIST criteria
- Duration of response
- Toxicity as assessed by CTCAE v3
研究者
研究点 (16)
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