NCT00519896已完成2 期
Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the response of sunitinib (sunitinib malate) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with recurrent/metastatic iodine refractory well differentiated thyroid carcinoma (WDTC) or medullary thyroid carcinoma (MTC).
SECONDARY OBJECTIVES:
I. Evaluate early positron emission tomography (PET) changes in patients with WDTC and MTC treated with sunitinib.
II. Determine the safety and toxicity of sunitinib given as a continuous treatment in patients with WDTC and MTC.
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
- •Histologically or cytologically proven metastatic WDTC or MTC
- •Evidence of refractoriness to iodine therapy for WDTC documented by a combination of imaging and thyroglobulin or by biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- •Evidence of fludeoxyglucose F 18 (FDG) PET avid metastatic tumors
- •Measurable disease by RECIST criteria
- •Resolution of all acute toxic effects of prior systemic therapy (including iodine therapy or chemotherapy), radiotherapy or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade =< 1
- •Total serum bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert's disease exempt)
- •Serum transaminases =< 2.5 x ULN or =< 5.0 X ULN if secondary to liver metastases
- •Serum creatinine =< 1.5 x ULN
- •Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
- •Platelets >= 100,000/uL
- •Hemoglobin >= 9.0 g/dL
- •Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- •Male and female patients with reproductive potential must use an acceptable contraceptive method
- •Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
排除标准
- •Concomitant treatment in another therapeutic clinical trial
- •ECOG performance status >= 3
- •Symptomatic, untreated, brain metastasis
- •Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
- •Full-dose anticoagulation defined as:
- •Low molecular weight heparin use with the intent of full dose anticoagulation; example: enoxaparin 1.5 mg/kg daily or equivalent
- •Warfarin use to keep international normalized ratio (INR) greater than or equal to 2
- •History of gross hemoptysis (defined as bright red blood of at least 1/2 teaspoon or 2.5 mL per episode) within 3 months prior to study drug administration unless definitively treated with surgery or radiation
- •Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism; ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >= 2
- •Type I Diabetes Mellitus; patients with Type II Diabetes Mellitus will be included as long as their glucose can be controlled between levels of 80 and 150 mg/dL
- •Uncontrolled Hypertension (> 150/100 mm Hg despite optimal medical therapy)
- •Major surgery or radiation therapy within 4 weeks of starting the study treatment
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- •Pregnancy or breast feeding
研究组 & 干预措施
Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)
Experimental
Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
次要结局
- Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0(On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years)
- Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease(At 30 days from the last dose of study treatment and then for 2 years)
研究者
Renato Martins
Principal Investigator
University of Washington
研究点 (1)
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