NCT00072267已完成2 期
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced 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
- 4
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Secondary
- Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.
- Determine the progression-free, median, and overall survival of patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
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 or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- •Progressive, persistent, or recurrent disease
- •Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy
- •Tumor lesions accessible for biopsy
- •Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator
- •No more than 2 prior chemotherapy regimens
- •At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin)
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 12 weeks
- •Hematopoietic
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST/ALT no greater than 2.5 times ULN
- •Creatinine no greater than ULN OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular
- •No history of coronary artery disease
- •No symptomatic cardiac dysfunction
- •No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram
- •No symptomatic pulmonary dysfunction
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 8 weeks after study participation
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents
- •No insulin-dependent diabetes mellitus
- •Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator
- •No other concurrent uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior biologic therapy and recovered
- •Chemotherapy
- •See Disease Characterisitcs
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No prior topotecan
- •No other prior topoisomerase I inhibitors
- •Endocrine therapy
- •More than 4 weeks since prior hormonal therapy and recovered
- •Radiotherapy
- •See Disease Characteristics
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排除标准
- 未提供
研究者
研究点 (4)
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