NCT00245102已完成2 期
A Multicenter Phase II Study of Sorafenib (BAY43-9006) in Non-GIST Sarcomas
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
- 147
- 试验地点
- 1
- 主要终点
- Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST
研究概览
简要总结
This phase II trial is studying how well sorafenib works in treating patients with metastatic, locally advanced, or recurrent sarcoma. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. The primary endpoint is the response rate (CR+PR) for each stratum of sarcoma patients treated with sorafenib as defined by RECIST.
SECONDARY OBJECTIVES:
I. Progression-free survival (defined as CR + PR + SD, assessed at 3 months or 6 months).
II. Overall survival. III. Pharmacokinetics of sorafenib in this patient population (all sites will participate).
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 confirmed sarcoma, including any of the following neoplastic subtypes:
- •Giant hemangioma
- •Angiosarcoma (including epithelioid hemangioendothelioma)
- •Malignant peripheral nerve sheath tumor
- •Leiomyosarcoma (closed to accrual as of 11/29/06)
- •High-grade undifferentiated pleomorphic sarcoma (i.e., malignant fibrous histiocytoma [including myxofibrosarcoma]) (closed to accrual as of 11/29/06)
- •Synovial sarcoma (closed to accrual as of 11/29/06)
- •Carcinosarcoma (closed to accrual as of 11/29/06)
- •Metastatic, locally advanced, or locally recurrent disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Lesions in a previously irradiated area may be considered measurable provided there is evidence of subsequent disease progression that cannot be attributed to necrosis or bleeding
- •No gastrointestinal stromal tumor
- •No known brain metastases
- •Performance status - ECOG 0-2
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No evidence of bleeding diathesis
- •Bilirubin ≤ 1.5 mg/dL
- •INR ≤ 1.5
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine ≤ 1.5 mg/dL
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled hypertension
- •No history of allergic reaction to compounds of similar chemical or biologic composition to sorafenib
- •No known HIV positivity
- •No active or ongoing infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No psychiatric illness or social situation that would preclude study compliance
- •No swallowing dysfunction that would preclude the swallowing of tablets
- •Other malignancies allowed provided sarcoma is the primary disease requiring treatment
- •No other uncontrolled illness
- •No more than 1 prior chemotherapy regimen for recurrent or metastatic disease (≤ 3 regimens for angiosarcoma or malignant peripheral nerve sheath tumor)
- •Adjuvant chemotherapy completed > 1 year prior to study entry is not considered a line of prior treatment
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •At least 3 weeks since prior radiotherapy
- •Recovered from prior antitumor therapy
- •Alopecia allowed
- •No prior sorafenib
- •No prior small molecule inhibitors of MAPK signaling intermediates
- •No concurrent therapeutic anticoagulation
- •Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial devices allowed provided requirements for PT, INR, or PTT requirements are met
- •No other concurrent investigational agents
- •No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
- •No concurrent rifampin or Hypericum perforatum (St. John's wort)
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Overall Response Rate Measured by Complete Response (CR) Rate and Partial Response (PR) Rate as Determined by RECIST
时间窗: Up to 4 weeks
A 5% response rate is considered not promising, a 20% response rate is considered promising. For each stratum, the response rate will be estimated and a confidence interval will be constructed.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Sorafenib Tosylate in Treating Patients With Malignant Mesothelioma.Epithelial MesotheliomaRecurrent Malignant MesotheliomaSarcomatous MesotheliomaStage IA Malignant MesotheliomaStage IB Malignant MesotheliomaStage II Malignant MesotheliomaStage III Malignant MesotheliomaStage IV Malignant MesotheliomaNCT00107432National Cancer Institute (NCI)44
已完成
2 期
Sorafenib in Treating Patients With Metastatic Breast CancerRecurrent Breast CancerStage IV Breast CancerMale Breast CancerNCT00096434National Cancer Institute (NCI)23
已完成
2 期
S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or CholangiocarcinomaAdenocarcinoma of the Extrahepatic Bile DuctAdenocarcinoma of the GallbladderAdenocarcinoma With Squamous Metaplasia of the GallbladderCholangiocarcinoma of the Extrahepatic Bile DuctCholangiocarcinoma of the GallbladderRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerSquamous Cell Carcinoma of the GallbladderUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder CancerNCT00238212National Cancer Institute (NCI)50
已完成
2 期
Sorafenib in Treating Patients With Relapsed or Refractory Multiple MyelomaRefractory Multiple MyelomaNCT00253578National Cancer Institute (NCI)40
已完成
2 期
Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's LymphomaAngioimmunoblastic T-cell LymphomaHepatosplenic T-cell LymphomaPeripheral T-cell LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaAnaplastic Large Cell LymphomaNCT00131937National Cancer Institute (NCI)14