NCT00017446Unknown2 期
Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas
Herbert Irving Comprehensive Cancer Center1 个研究点 分布在 1 个国家开始时间: 2000年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 1
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.
PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.
详细描述
OBJECTIVES:
- Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma.
- Determine the clinical toxic effects of this drug in these patients.
OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
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
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed soft tissue sarcoma
- •Metastatic or locally advanced
- •Failed at least 1 prior therapy
- •Measurable disease outside prior irradiation field
- •No CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •Creatinine less than 1.5 times ULN
- •Calcium less than ULN
- •Potassium normal
- •No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior biologic response modifier therapy allowed
- •Chemotherapy:
- •No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy for malignancy
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •At least 4 weeks since prior surgery and recovered
- •No other concurrent cardiac glycosides
排除标准
- 未提供
研究者
研究点 (1)
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