NCT00004866已完成2 期
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Advanced or Recurrent Squamous Cell Cancer of the Cervix
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 6
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 DX-8951f in treating women who have advanced or recurrent cancer of the cervix.
详细描述
OBJECTIVES:
- Determine the antitumor activity of DX-8951f in women with advanced or recurrent squamous cell carcinoma of the cervix.
- Evaluate the quantitative and qualitative toxic effects of this regimen in these patients.
- Evaluate the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until death.
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 advanced or recurrent squamous cell carcinoma of the cervix not curable by surgery or radiotherapy
- •Measurable disease
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT or SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No active congestive heart failure
- •No uncontrolled angina
- •No myocardial infarction within the past 6 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent serious infection
- •No other malignancy within the past 5 years except nonmelanomatous skin cancer
- •No other life threatening illness
- •No psychosis, mental disability, or incompetence
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy
- •No more than 1 prior chemotherapy regimen (except chemotherapy for radiosensitization)
- •No prior camptothecin
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •At least 4 weeks since prior surgery
- •No concurrent surgery
- •At least 4 weeks since other prior investigational drugs (including analgesics or antiemetics)
- •No other concurrent investigational drugs during or within 28 days after final dose of study drug
- •No concurrent drugs that induce or inhibit CYP3A enzyme
排除标准
- 未提供
研究者
研究点 (6)
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