NCT00005999已完成2 期
A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have stage IVB or recurrent cervical cancer.
详细描述
OBJECTIVES:
- Evaluate the efficacy of arsenic trioxide in patients with stage IVB or recurrent cervical carcinoma.
- Determine the safety of this treatment in these patients.
OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 10-19 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IVB or recurrent cervical carcinoma that is not amenable to standard curative therapies
- •Squamous carcinoma OR
- •Adenocarcinoma
- •Measurable disease
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •Nonmeasurable disease defined as any of the following:
- •Bone disease
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed or followed by imaging techniques
- •Cystic lesions
- •No active brain metastases
- •PATIENT CHARACTERISTICS:
- •17 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2.5 times ULN
- •Creatinine no greater than 2.0 mg/dL OR
- •Creatinine clearance at least 50 mL/min
- •Cardiovascular:
- •No cardiac arrhythmias, unstable angina, or conduction abnormalities
- •No New York Heart Association class III or IV heart disease or clinical evidence of congestive heart failure
- •Pretreatment QTc less than 500 msec
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 months after study
- •No grade 3 or greater neurologic abnormalities
- •No history of seizures
- •No concurrent uncontrolled active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No more than 2 prior therapies for advanced disease
- •Chemotherapy:
- •No more than 2 prior therapies for advanced disease
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •No more than 2 prior therapies for advanced disease
- •Radiotherapy:
- •No more than 2 prior therapies for advanced disease
- •At least 4 weeks since prior radiotherapy
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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