NCT00003065已完成2 期
Phase II Investigation of Topotecan and Taxol in Patients With Recurrent/Metastatic Cancer of the Cervix
Herbert Irving Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 1997年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix.
详细描述
OBJECTIVES:
- Determine the response, time to progression, disease free survival, and overall survival of patients with recurrent and/or metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel.
- Determine the feasibility and toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Filgrastim (G-CSF) is administered on days 6-14. Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 weeks.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed recurrent, persistent or metastatic cervical carcinoma (squamous or adenocarcinoma), with no potentially curative standard treatment
- •Measurable disease or evaluable disease
- •PATIENT CHARACTERISTICS:
- •18 to physiological 60
- •Performance status:
- •Life expectancy:
- •Greater than 2 months
- •Hematopoietic:
- •WBC greater than 3000/mm3
- •Platelet count greater than 100,000/mm3
- •Bilirubin less than 1.5 times normal
- •SGOT/SGPT less than 1.5 times normal
- •BUN less than 1.5 times normal
- •Creatinine less than 1.5 times normal
- •Creatinine clearance greater than 50 mL/min
- •Ineligible for other high priority national or institutional study
- •Not pregnant or nursing
- •HIV negative
- •No prior malignancy except nonmelanoma skin cancer
- •No serious medical or psychiatric illness preventing treatment or informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Greater than 4 weeks since prior chemotherapy
- •No greater than 2 prior chemotherapy regimens
- •No prior taxane or camptothecin
- •Endocrine therapy:
- •No concurrent hormonal therapy except that required for nondisease related conditions (e.g., insulin for diabetes)
- •Radiotherapy:
- •Greater than 4 weeks since prior radiation therapy
- •No concurrent radiation therapy
- •Greater than 4 weeks since prior surgery
排除标准
- 未提供
研究者
研究点 (1)
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