Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer
Phase II Trial of Thalidomide in Patients With Ovarian Cancer
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.
研究概览
详细说明
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.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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New York
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New York、New York、美国、10021
- Memorial Sloan-Kettering Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age:
- Over 18
Performance status:
- Karnofsky 70-100%
Life expectancy:
- More than 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin normal
- AST no greater than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 1.5 times ULN OR
- Creatinine clearance at least 50 mL/min
Other:
- 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
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior major surgery
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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