NCT00114153已完成1 期
Phase I Trial of Induction Paraplatin® and Xeloda® Followed by Concurrent Paraplatin and Xeloda With Intensity Modulated Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with carboplatin followed by radiation therapy in treating patients with stage III or stage IV head and neck cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of capecitabine when administered with carboplatin as induction chemotherapy in patients with stage III-IVB squamous cell carcinoma of the head and neck.
- Determine the MTD of capecitabine when administered with concurrent carboplatin and intensity-modulated radiotherapy in these patients.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine, preliminarily, tumor response in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the head and neck, including 1 of the following types:
- •Oral cavity
- •Oropharynx
- •Hypopharynx
- •Clinical stage III-IVB (T2-T4, N0-N3, M0) disease
- •Measurable disease by physical exam, endoscopy, and/or CT scan or MRI
- •Residual measurable disease after fine needle aspiration, core needle biopsy, or incisional or excisional biopsy of the primary tumor
- •No evidence of distant metastases (M1)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 9 g/dL
- •No uncontrolled coagulopathy
- •AST < 2 times normal
- •Alkaline phosphatase < 2 times normal
- •Bilirubin normal
- •Creatinine < 2.0 mg/dL OR
- •Creatinine clearance > 50 mL/min
- •Cardiovascular
- •No congestive heart failure
- •No symptomatic coronary artery disease
- •No uncontrolled cardiac arrhythmias
- •No myocardial infarction within the past year
- •No other clinically significant cardiac disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment
- •Nutritional and general physical condition must be compatible with proposed study treatment
- •Mentally reliable
- •No pre-existing peripheral neuropathy > grade 1
- •No history of hypersensitivity to fluorouracil, capecitabine, or carboplatin
- •No active infection
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •No major medical, psychiatric, or neurologic illness that would preclude study participation or giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 5 years since prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy for head and neck tumor
- 另有 5 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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