NCT00006224终止2 期
Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 78
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 gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.
详细描述
OBJECTIVES:
- Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable
- •Eligible subtypes:
- •Adenocarcinoma
- •Adenosquamous carcinoma
- •Undifferentiated carcinoma
- •Must have documented disease progression
- •Histologic confirmation of original primary tumor required
- •Bidimensionally measurable disease
- •Ineligible for higher priority GOG protocol
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count at least 100,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Bilirubin no greater than 1.5 times normal
- •SGOT and alkaline phosphatase no greater than 3 times normal
- •Creatinine no greater than 1.5 mg/dL
- •No significant infection
- •Not pregnant
- •Fertile patients must use effective contraception
- •No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent filgrastim (G-CSF)
- •Chemotherapy:
- •No prior gemcitabine
- •At least 3 weeks since other prior chemotherapy for cervical cancer and recovered
- •No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy)
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •At least 3 weeks since prior radiotherapy for cervical cancer and recovered
- •At least 3 weeks since prior surgery for cervical cancer and recovered
- •No prior cancer treatment that would preclude study
排除标准
- 未提供
研究者
研究点 (78)
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