Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer
A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.
研究概览
地位
条件
详细说明
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)
- To evaluate the disease-free survival of patients treated with this regimen. (Phase II)
Secondary
- To identify dose-limiting toxicities in these patients treated with this regimen. (Phase I)
- To assess the safety and tolerability of this regimen. (Phases I and II)
- To assess progression-free survival and survival of patients treated with this regimen. (Phase I)
- To assess overall survival in patients treated with this regimen. (Phase II)
- To assess response rates in patients treated with this regimen. (Phases I and II)
OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation followed by a phase II study.
Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes, and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D conformal or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 4 years.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
-
-
Texas
-
Dallas、Texas、美国、75204
- Baylor Research Institute
-
Dallas、Texas、美国、75239
- University of Texas Southwestern Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx
- Diagnosis based on the primary lesion and/or lymph nodes
- Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)
- No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands
- No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-1
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve hemoglobin > 8.0 g/dL allowed)
- Bilirubin ≤ 1.5 mg/dL
- AST, ALT, and AP ≤ 2.5 times upper limit of normal
- Serum creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0:
- Calcium < 7 mg/dL or > 12.5 mg/dL
- Glucose < 40 mg/dL or > 250 mg/dL
- Magnesium < 0.9 mg/dL or > 3 mg/dL
- Potassium < 3 mmol/L or > 6 mmol/L
- Sodium < 130 mmol/L or > 155 mmol/L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless disease-free for ≥ 3 years
- No prior allergic reaction to study drugs
No active cardiac disease, defined as any of the following:
- Unstable angina
- Uncontrolled hypertension
- Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
- Uncontrolled arrhythmia
- Congestive heart failure
- Three or more heart-related hospitalizations within the past year
- No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
- No AIDS
- No pre-existing peripheral sensory neuropathy ≥ grade 2
- No concurrent medical illnesses that would impair patient tolerance to therapy or limit survival
PRIOR CONCURRENT THERAPY:
No prior systemic chemotherapy for this cancer
- Prior systemic chemotherapy for a different cancer allowed
- No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
- No prior initial surgical treatment (excluding diagnostic biopsy of the primary site or nodal sampling of neck disease)
- At least 48 hours since prior and no concurrent granulocytic growth factors (e.g., filgrastim [G-CSF]) during radiotherapy
- No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:arm one
Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy
|
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor
Cisplatin is an anti-cancer chemotherapy drug
其他名称:
paclitaxel albumin-stabilized nanoparticle formulation
其他名称:
intensity-modulated radiation therapy
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Phase I Maximum Tolerated Dose of Nab-Paclitaxel
大体时间:90 days
|
Seven participants were assigned nab-paclitaxel in dose of 25mg/m^2.
Five participants were assigned nab-paclitaxel in dose of 20mg/m^2.
|
90 days
|
Phase II 2-year Progression-free Survival
大体时间:2 year
|
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death. |
2 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Phase II 2-year Local Control
大体时间:2 year
|
Local control is defined as the arrest cancer growth at the site of origin.
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions
|
2 year
|
Phase II 2-year Overall Survival
大体时间:2 year
|
median follow-up 24 months for 34 patients
|
2 year
|
合作者和调查者
调查人员
- 首席研究员:Hak Choy, MD、Simmons Cancer Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STU 072010-046
- SCCC-112008-019
- CDR0000634258
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Cetuximab的临床试验
-
Pfizer招聘中实体瘤美国, 西班牙, 加拿大, 意大利, 澳大利亚, 匈牙利, 荷兰, 英国, 德国, 巴西, 大韩民国, 葡萄牙, 法国, 日本, 以色列, 斯洛伐克, 捷克语