A Phase II Evaluation Of Docetaxel (NSC #628503) In The Treatment Of Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Survival time
研究概览
简要总结
Phase II trial to study the effectiveness of docetaxel in treating patients who have persistent or recurrent cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of docetaxel in patients with persistent or recurrent squamous cell carcinoma of the cervix.
II. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed persistent or recurrent squamous cell carcinoma of the cervix
- •Progressive disease
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •Tumors within a previously irradiated field are not considered target lesions
- •One prior systemic chemotherapeutic regimen for advanced, metastatic, or recurrent squamous cell carcinoma of the cervix required
- •Chemotherapy administered as a radiosensitizer in conjunction with primary radiotherapy is not considered a systemic chemotherapy regimen
- •Ineligible for a higher priority GOG protocol (e.g., any active Phase III GOG protocol or GOG-0076)
- •Performance status - GOG 0-2
- •Absolute neutrophil count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No congestive heart failure
- •No unstable angina, myocardial infarction, or new cardiac arrhythmia within the past 6 months
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics
- •No greater than grade 1 sensory and motor neuropathy
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •At least 3 weeks since prior biologic or immunologic therapy directed at malignant tumor
- •One prior noncytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule signal transduction inhibitors) for recurrent or persistent disease allowed
- •Recovered from prior chemotherapy
- •No prior docetaxel
- •No more than 1 prior cytotoxic chemotherapy regimen
- •At least one week since prior hormonal therapy directed at malignant tumor
- •Concurrent hormone replacement therapy allowed
- •Recovered from prior radiotherapy
- •Recovered from recent prior surgery
- •At least 3 weeks since any prior therapy directed at malignant tumor
- •No prior anticancer therapy that would preclude study
- •No concurrent amifostine or other protective agents
排除标准
- 未提供
研究组 & 干预措施
Treatment (docetaxel)
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Survival time
时间窗: 5 years
Frequency and severity of observed adverse effects
时间窗: 5 years
Frequency and duration of objective response as assessed on radiologic scan
时间窗: 5 years
Duration of progression-free interval
时间窗: 5 years
次要结局
未报告次要终点