Phase II Study of BAY 43-9006 in Patients With Metastatic Thyroid Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have locally advanced, metastatic, or locally recurrent thyroid cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Determine objective response rate in patients with locally advanced, metastatic, or locally recurrent differentiated thyroid cancer treated with sorafenib (BAY 43-9006).
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients. II. Correlate thyroglobulin levels with tumor response in patients treated with this drug.
III. Correlate fludeoxyglucose F 18 positron emission tomography results with tumor response in patients treated with this drug.
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 confirmed diagnosis of 1 of the following:
- •Papillary thyroid cancer (stratum I)
- •Papillary, follicular, Hurthle cell, insular, or anaplastic thyroid cancer (stratum II)
- •Mixed histology, poorly differentiated, or tall-cell variants allowed
- •Metastatic, locally advanced, or locally recurrent disease
- •At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •The following are considered non-measurable disease:
- •Tumors in a previously irradiated area
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •Archival tumor tissue block OR material collected before study entry available (stratum I)
- •Biopsy-accessible disease (stratum I)
- •Performance status - ECOG 0-1
- •At least 6 months
- •WBC >= 3,000/mm^3
- •Absolute neutrophil count >= 1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •No bleeding diathesis
- •Bilirubin =< 1.5 times upper limit of normal (ULN)
- •AST and ALT =< 1.5 times ULN
- •Creatinine =< 1.5 times ULN
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Willing to undergo 2 tumor biopsies during study participation (stratum I)
- •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to sorafenib
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other uncontrolled illness
- •No other concurrent malignancy except nonmetastatic nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No prior systemic chemotherapy for thyroid cancer (stratum I)
- •Prior systemic chemotherapy used to treat a second primary cancer with curative intent allowed provided the primary cancer was treated more than 5 years before study entry
- •No more than 3 prior systemic chemotherapy regimens for thyroid cancer (stratum II)
- •More than 6 weeks since prior systemic chemotherapy (stratum II)
- •No prior external beam radiotherapy to the sole site of measurable disease (except for patients with anaplastic thyroid cancer)
- •More than 6 weeks since prior external beam radiotherapy
- •More than 24 weeks since prior iodine I 131
- •Recovered from all prior therapy
- •No prior sorafenib
- •More than 6 weeks since prior investigational tumor-specific therapy
- •Concurrent oral or IV bisphosphonates for bony metastases allowed at the discretion of the investigator
- •No other concurrent tumor-specific or investigational therapy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No concurrent therapeutic anticoagulation
- •Concurrent prophylactic anticoagulation (e.g., low-dose warfarin) for venous or arterial access devices allowed provided PT, INR, or PTT are normal
排除标准
- 未提供
研究组 & 干预措施
Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.
干预措施: sorafenib tosylate (Drug)
Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.
干预措施: laboratory biomarker analysis (Other)
Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.
干预措施: pharmacological study (Other)
Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.
干预措施: fludeoxyglucose F 18 (Radiation)
Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.
干预措施: positron emission tomography (Procedure)
Treatment (sorafenib tosylate)
Patients receive oral sorafenib tosylate twice daily for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 8 additional weeks of therapy beyond CR.
干预措施: dynamic contrast-enhanced magnetic resonance imaging (Procedure)
结局指标
主要结局
Objective response rate
时间窗: Up to 4 weeks
The 95% confidence intervals should be provided.
次要结局
- Incidence of toxicity(Up to 4 weeks)