NCT00060242已完成2 期
Phase II Trial Of Combretastatin A-4 Phosphate (CA4P) In Advanced Anaplastic Carcinoma Of The Thyroid
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Median survival
研究概览
简要总结
RATIONALE: Combretastatin A4 phosphate may stop the growth of anaplastic thyroid cancer by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well combretastatin A4 phosphate works in treating patients with advanced recurrent or metastatic anaplastic thyroid cancer.
详细描述
OBJECTIVES:
- Determine the objective response rate of patients with advanced anaplastic thyroid cancer treated with combretastatin A4 phosphate.
- Determine whether this drug alters the natural history of anaplastic thyroid cancer, in terms of doubling the median survival from 4-6 months to 12 months, in these patients.
- Determine the safety profile of this drug in these patients.
- Correlate clinical response with pretreatment tumor microvessel density and immature vessel staining, changes in sICAM-1 levels over the course of treatment, and pharmacokinetic parameters in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive combretastatin A4 phosphate IV over 10 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses beyond documentation of the CR.
Patients are followed monthly.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed* anaplastic or poorly differentiated variant thyroid cancer, including 1 of the following:
- •Recurrent/regionally advanced disease no longer amenable to definitive curative surgery or radiotherapy
- •Untreated metastatic disease NOTE: *If original/diagnostic tumor blocks are unavailable, tumor must be accessible for pretreatment core needle biopsy
- •Must have relapsed or progressed during or after prior combined modality therapy (e.g., systemic chemotherapy and radiotherapy) for regionally advanced (but not metastatic) disease
- •Measurable or evaluable disease
- •Patent trachea and airway by screening direct and indirect laryngoscopy* NOTE: *For patients with bulky thyroid/neck masses and/or suspected airway obstruction
- •No active brain metastases, as evidenced by any of the following:
- •Symptomatic involvement
- •Cerebral edema by CT scan or MRI
- •Radiographic evidence of progression since definitive therapy
- •Continued requirement for corticosteroids
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 75,000/mm^3
- •Hemoglobin at least 8.5 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •ALT and AST no greater than 3.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •LVEF at least 50% by MUGA
- •EKG normal
- •No evidence of prior myocardial infarction (e.g., significant Q waves), QTc greater than 450 msec, or other clinically significant abnormalities
- •No history of angina (even if controlled by medication)
- •No congestive heart failure
- •No uncontrolled atrial arrhythmias
- •No clinically significant arrhythmias, including any of the following:
- •Conduction abnormalities
- •Nodal junctional arrhythmias and dysrhythmias
- •Sinus bradycardia or tachycardia
- •Supraventricular arrhythmias
- •Atrial fibrillation or flutter
- •Syncope or vasovagal episodes
- •No significant heart wall abnormality or heart muscle damage by MUGA
- •No uncontrolled hypertension (blood pressure consistently greater than 150 mm Hg systolic and 100 mm Hg diastolic regardless of medication)
- •Patients with previous hypertension are allowed provided there is clinical documentation of controlled blood pressure for 2 months prior to study enrollment
- •No symptomatic peripheral vascular disease
- •No symptomatic cerebrovascular disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No grade 2 or greater preexisting motor or sensory peripheral neuropathy
- •No uncontrolled hypokalemia or hypomagnesemia
- •No concurrent serious infection
- •No other nonmalignant medical illness that is uncontrolled or whose control may be jeopardized by study therapy
- 另有 29 项未显示
排除标准
- 未提供
结局指标
主要结局
Median survival
时间窗: every 8 weeks
次要结局
- Objective disease response(every 8 weeks)
研究者
研究点 (3)
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