NCT00016224已完成2 期
Phase II Trial of Thalidomide in Patients With Ovarian Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.
详细描述
OBJECTIVES:
- Determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide.
- Evaluate the quality of life of patients treated with this regimen.
OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 4 weeks.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial carcinoma
- •Platinum-refractory or resistant disease
- •At least 1 prior non-platinum chemotherapy agent required
- •Prior bilateral salpingo-oophorectomy and hysterectomy required
- •Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Not specified
- •Bilirubin normal
- •AST no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN OR
- •Creatinine clearance at least 50 mL/min
- •No other prior malignancy except non-melanoma skin cancer unless curatively treated with no evidence of disease within the past 5 years and at low risk for recurrence
- •No other clinical circumstances that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy and recovered
- •No prior thalidomide
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior cytotoxic therapy and recovered
- •Endocrine therapy:
- •At least 4 weeks since prior hormonal therapy and recovered
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior major surgery
排除标准
- 未提供
研究者
研究点 (1)
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