NCT00083057已完成1 期
A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) as assessed by CTC v. 3.0
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma (cancer) of the head and neck.
详细描述
OBJECTIVES:
Primary
- Determine the dose-limiting toxicity, toxicity profile, and maximum tolerated dose (MTD) of gefitinib and paclitaxel administered with radiotherapy in patients with advanced or recurrent squamous cell carcinoma of the head and neck.
Secondary
- Determine the efficacy of this regimen in patients treated at the MTD.
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 or cytologically confirmed squamous cell (epidermoid) carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or maxillary sinus
- •Stage III or IV disease
- •Distant metastases allowed provided both of the following are true:
- •Metastases are confined to the head and neck region
- •Metastases are encompassable in a radiotherapy field with curative intent
- •Locally recurrent disease after primary surgery allowed
- •Meets 1 of the following criteria:
- •Unresectable disease
- •Patient prefers chemoradiotherapy over surgery
- •Measurable disease
- •No brain metastases and/or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Hemoglobin > 10 g/dL
- •Platelet count > 100,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Bilirubin < 2.0 times upper limit of normal (ULN)
- •AST/ALT ≤ 2.5 times ULN
- •Creatinine < 1.5 times ULN OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No clinically active interstitial lung disease
- •Chronic, stable, asymptomatic radiographic changes allowed
- •No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or Cremophor^® EL
- •No AIDS or primary immunodeficiencies
- •No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
- •Probability of recurrence of the prior malignancy < 5%
- •No other concurrent uncontrolled illness
- •No ongoing or active serious infection
- •No psychiatric illness or situation that would preclude study compliance or giving informed consent
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for cancer
- •No other concurrent chemotherapy
- •Endocrine therapy
- 另有 20 项未显示
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) as assessed by CTC v. 3.0
次要结局
- Molecular targets analysis of epidermal growth factor receptor (EGFR) downstream signaling pathway as assessed by tissue biopsies and serum cytokines at baseline, days 8 and 29, and 12 weeks after completion of study treatment
- Efficacy as assessed by imagining, histologically, and clinically at 3 months after completion of study treatment and annually for 5 years
研究者
研究点 (4)
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