NCT03614364Unknown2 期
Combination of Nanoxel and Herzuma as First-line Chemotherapy in Patients With Metastatic Salivary Duct Carcinoma : Open Label Single Arm Multicenter Phase II Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
- Study outline This is a multicenter, single-arm, phase II trial to evaluate the efficacy and safety of nanoxel plus herzuma combination chemotherapy in patients with metastatic salivary ductal cancer. Approximately 41 patients will be enrolled. Treatment will be continued until disease progression or unacceptable toxicities. Response evaluation will be performed every 2 cycles.
- Dosing & Treatment schedule D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks (In case of discontinuation of nanoxel without progression, single agent herzuma can be administered until progression)
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed HER2 positive (immunohistochemistry [IHC] 3+, and/or fluorescence in situ hybridization[FISH] positive with ≥ two-fold amplification) salivary duct carcinoma(SDC), and other salivary gland carcinomas which are similar to SDC in histopathological findings, including adenocarcinoma, not otherwise specified, acinic cell carcinoma, squamous cell carcinoma, anaplastic carcinoma, high grade mucoepidermoid carcinoma, and carcinoma ex pleomorphic adenoma
- •stage IV or recurrent cancer
- •age ≥ 20 years
- •ECOG performance status 0-2
- •At least one measurable tumor lesion according to RECIST 1.1
- •Expected survival for approximately 12 weeks or longer
- •No prior systemic chemotherapy
- •At least 4 weeks later after surgery or radiotherapy
- •Written informed consent
排除标准
- •Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal medication and/or coronary angioplasty (including stent placement) within the preceding 24 months(congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias)
- •Uncontrolled systemic illness such as DM, hypertension, hypothyroidism and infection
- •Pregnant and nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
- •Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
- •Patients with alcohol abuse
研究组 & 干预措施
nanoxel and herzuma
Experimental
D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks
干预措施: nanoxel (Drug)
nanoxel and herzuma
Experimental
D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks
干预措施: herzuma (Drug)
结局指标
主要结局
Response rate
时间窗: about 24months
according to RECIST version 1.1
次要结局
未报告次要终点
研究者
Myung-Ju Ahn
Professor
Samsung Medical Center
研究点 (1)
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