NCT00498953已完成1 期
Phase I/II Study on Induction Chemotherapy Followed by Chemoradiation With or Without Lapatinib, a Dual EGFR/ErbB2 Kinase Inhibitor, in Patients With Locally Advanced Larynx and Hypopharynx Squamous Cell Carcinoma
European Organisation for Research and Treatment of Cancer - EORTC1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2007年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of lapatinib ditosylate (Phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, fluorouracil, and carboplatin, 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. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with radiation therapy, with or without lapatinib, before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed or eliminate the need for surgery.
PURPOSE: This phase I/II trial is studying the side effects and best dose of combination chemotherapy given together with radiation therapy with or without lapatinib and to see how well it works in treating patients with locally advanced cancer of the larynx or hypopharynx.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and recommended dose for phase II of lapatinib ditosylate in patients with locally advanced squamous cell carcinoma of the larynyx or hypopharynx who are concomitantly treated with neoadjuvant induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil, followed by chemoradiotherapy comprising carboplatin and radiotherapy. (Phase I)
- To document the feasibility, in the framework of an organ preservation program, of this regimen in these patients. (Phase II)
Secondary
- To look at the role of PET in patients with N1-3 disease, in terms of PET being used as a reliable method to spare patients from planned neck dissection. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed squamous cell carcinoma of the larynx or hypopharynx
- •T3 or T4 disease of the larynx or T2, T3 or T4 disease of the hypopharynx
- •Nodal status must be N0, N1, N2a, N2b, N2c or N3
- •Resectable or unresectable disease (Phase I patients only)
- •Patient must have tumors amenable to surgery (Phase II patients only)
- •No distant metastasis
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin < 1.5 times the upper limit of the normal range
- •Alkaline phosphatase and transaminases < 2.5 times the upper limit of the normal range
- •Serum creatinine < 1.7 mg/dL
- •All patients (male and female) must use effective contraception methods if of reproductive potential (e.g., implants, injectables, combined oral contraceptives, IUDs, sexual abstinence, or vasectomized partner)
- •Females must not be pregnant or lactating
- •Patients must have normal cardiac function (LVEF assessed by MUGA or ECHO) and clinically satisfactory 12-lead ECG
- •No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
- •History of documented congestive heart failure
- •High-risk uncontrolled arrhythmias
- •Angina pectoris requiring antianginal medication
- •Clinically significant valvular heart disease
- •Evidence of transmural infarction on ECG
- •Poorly controlled hypertension (e.g., systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)
- •Patients should be able to swallow oral agents
- •No current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least five years
- •Absence of any unstable systemic diseases or active uncontrolled infections
- •Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •PRIOR CONCURRENT THERAPY:
- •No other prior therapy for head and neck cancer
- •More than 10 days since prior and no concurrent CYP3A4 inducers, including the following:
- •Antibiotics (e.g., all rifamycin class agents [rifampicin, rifabutin, or rifapentine])
- •Anticonvulsants (e.g., phenytoin, carbamezepine, or barbiturates [phenobarbital])
- •Oral glucocorticoids (e.g., cortisone [> 50 mg], hydrocortisone [> 40 mg], prednisone [> 10 mg], methylprednisolone [> 8 mg], or dexamethasone [> 1.5 mg])
- •Antiretrovirals (e.g., efavirenz or nevirapine)
- •Other (hypericum perforatum [St. John's Wort] or modafinil)
- •More than 10 days since prior and no concurrent CYP3A4 inhibitors, including the following:
- •Antibiotics (e.g., clarithromycin, erythromycin, or troleandomycin)
- •Antifungals (e.g., itraconazole, ketoconazole, fluconazole [> 150 mg daily], or voriconazole)
- •Antiretrovirals and protease inhibitors (e.g., delavirdine, nelfinavir, amprenavir, ritonavir, indinavir, saquinavir, or lopinavir)
- •Calcium channel blockers (e.g., verapamil or diltiazem)
- •Antidepressants (e.g., nefazodone or fluvoxamine)
- •Gastrointestinal agents (e.g., cimetidine or aprepitant)
- •Other (e.g., grapefruit, grapefruit juice, or camiodarone)
- •Miscellaneous (e.g., antacids [Mylanta, Maalox, Tums, or Rennies], all herbal [bergamottin or glabridin] or dietary supplements)
- •Patients may not receive any other anticancer therapy or investigational agents while on study
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of lapatinib ditosylate (Phase I)
Dose-limiting toxicities of lapatinib ditosylate (Phase I)
Recommended dose of lapatinib ditosylate (Phase I)
Feasibility (Phase II)
次要结局
- Toxicity (Phase II)
- Survival with functional larynx (i.e., alive without local progression/relapse, tracheotomy, feeding tube, gastrostomy, or laryngectomy) (Phase II)
- Response rate (CR and PR) of neoadjuvant treatment (Phase II)
- Overall response rate (Phase II)
- Rate of local relapse (Phase II)
- Distant metastasis (Phase II)
- Overall survival (Phase II)
- Predictive value of PET to spare neck dissection in N1-3 patients (Phase II)
研究者
研究点 (1)
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