NCT00077103终止1 期
Phase II Trial of Combined Modality Combretastatin A-4 Phosphate (CA4P)-Based Therapy for Patients With Newly Diagnosed Anaplastic Thyroid Cancer [Induction Chemotherapy With Doxorubicin/Cisplatin; Combined Modality Therapy With CA4P and Radiation; Followed by 2 Cycles of CA4P Consolidation]
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Median survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combretastatin A4 phosphate may stop the growth of cancer by stopping blood flow to the tumor. Combining doxorubicin and cisplatin with radiation therapy and combretastatin A4 phosphate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving induction chemotherapy using doxorubicin and cisplatin together with radiation therapy and combretastatin A4 phosphate works in treating patients with newly diagnosed regionally advanced anaplastic thyroid cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with newly diagnosed regionally advanced anaplastic thyroid cancer treated with induction chemotherapy comprising doxorubicin and cisplatin followed by combretastatin A4 phosphate (CA4P) and radiotherapy.
- Determine whether this regimen alters the natural history of anaplastic thyroid cancer by virtue of doubling the median survival of these patients from 10 to 20 months.
Secondary
- Determine a tolerable dose of CA4P when administered with radiotherapy in these patients. (Phase I portion of the study closed as of 5/6/04; patients now receive a fixed dose of CA4P)
- Determine the safety profile of this regimen in these patients.
- Determine clinical predictors of response (e.g., pretreatment tumor microvessel density and immature vessel staining, changes in sICAM-1 levels and tumor blood flow, and pharmacokinetic parameters) in patients treated with this regimen.
- Correlate the diminution in blood flow with tumor pain and response in patients treated with this regimen.
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 carcinoma of either of the following:
- •Regionally advanced disease
- •Confined to the neck and/or superior mediastinum (i.e., above the level of the carina)
- •Measurable or evaluable* disease
- •Completely resected disease without measurable or evaluable disease NOTE: *At a minimum, abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed
- •Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry
- •Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy
- •Must undergo indirect and direct laryngoscopy to ensure patency of the trachea/airway if deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction
- •No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases
- •Superior mediastinal disease (i.e., above the level of the carina) in addition to regional neck disease is allowed provided the disease can be contained in a single radiotherapy port
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Hemoglobin ≥ 8.5 g/dL
- •Bilirubin ≤ 1.5 mg/dL
- •ALT and AST ≤ 3.5 times upper limit of normal
- •Creatinine ≤ 1.5 mg/dL
- •Cardiovascular
- •LVEF ≥ 50% by echocardiogram
- •EKG normal
- •No prior angina
- •No prior myocardial infarction (e.g., significant Q waves), QTc > 450 msec, or other clinically significant abnormalities on ECG
- •No congestive heart failure
- •No uncontrolled atrial arrhythmias or clinically significant arrhythmias, including any of the following:
- •Conduction abnormality
- •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 echocardiogram
- •No uncontrolled hypertension (i.e., blood pressure consistently greater than 150/100 mm Hg irrespective of medication)
- •Hypertension is allowed provided there is clinical documentation of controlled blood pressure for 2 months before study entry
- •No symptomatic peripheral vascular disease or cerebrovascular disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled hypokalemia or hypomagnesemia
- •No concurrent serious infection
- •No other nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of study therapy
- •No grade 2 or greater pre-existing motor or sensory peripheral neuropathy
- •No psychiatric disorder or other condition that would preclude study compliance
- •No conditions associated with QTc prolongation
- •PRIOR CONCURRENT THERAPY:
- 另有 22 项未显示
排除标准
- 未提供
结局指标
主要结局
Median survival
时间窗: at months 2, 4, 6, 8, 10, 12, 15, 18, 21, 24, 27, 30, 33, and 36
次要结局
- Objective disease response(at the end of induction, combined modality therapy, and consolidation therapy, at 2 months after completion of consolidation therapy, at 2 month intervals during year 1, and then 3 month intervals during years 2 and 3)
研究者
研究点 (3)
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