NCT00004920已完成3 期
Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
European Organisation for Research and Treatment of Cancer - EORTC51 个研究点 分布在 11 个国家目标入组 256 人开始时间: 1999年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 51
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.
详细描述
OBJECTIVES:
- Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin.
- Assess toxicity, progression free survival, and quality of life with these treatment regimens in these patients.
- Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease.
OUTLINE: This is a randomized, open, multicenter study. Patients are stratified according to performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive cisplatin IV over 1-2 hours on day 1.
- Arm II: Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1.
Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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 confirmed malignant pleural mesothelioma
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •ZUBROD, ECOG, WHO 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Hemoglobin at least 10.0 g/dL
- •WBC at least 4,000/mm^3
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.46 mg/dL
- •Albumin at least 3.0 g/dL
- •ALAT/ASAT less than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver involvement)
- •Creatinine less than 1.69 mg/dL
- •Creatinine clearance at least 65 mL/min
- •Cardiovascular:
- •Not specified
- •Not specified
- •No other prior or concurrent malignancies within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin
- •No prior malignant melanoma, hypernephroma or breast carcinoma
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study
- •No uncontrolled infections
- •No psychological, familial, sociological, or geographical condition that precludes study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy before first disease progression
- •Chemotherapy:
- •No prior systemic or intracavitary cytotoxic chemotherapy
- •No other prior or concurrent chemotherapy before first disease progression
- •No prior or concurrent pleurodesis with cytotoxic drugs (e.g., bleomycin)
- •Endocrine therapy:
- •No concurrent hormonal therapy except corticosteroids before first disease progression
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy to target lesion and progression observed
- •Concurrent palliative radiotherapy to painful lesions allowed only if target lesion outside of irradiated field
- •Prior surgery allowed if followed by disease progression
- •At least 1 month since prior investigational drugs
排除标准
- 未提供
研究者
研究点 (51)
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