Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
研究概览
简要总结
The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.
详细描述
An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma
- •Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed
- •Prior radiation therapy for head and neck cancer
- •Disease must be considered surgically resectable or candidate for curative reirradiation
- •Adequate diagnostic workup
- •Zubrod Performance Status 0-2
- •Life expectancy 12 weeks
- •Adequate laboratory data.
排除标准
- •Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)
- •Patients who are pregnant or lactating
- •Psychological condition that renders the patient unable to understand the informed consent
- •Any situation or condition that will interfere with adherence to study activities.
研究组 & 干预措施
Tarceva
All patients will be prescribed erlotinib 150mg daily
干预措施: Erlotinib (Drug)
结局指标
主要结局
Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment
时间窗: 12 - 24 months
Number of participants who had the most frequently observed undesirable effects after exposure to study drug
Percentage of Participants With Disease Free Status at 12 Months and 24 Months
时间窗: 12 - 24 months
Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)
次要结局
- Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.(12 - 24 months)
研究者
Eben Rosenthal
Professor of Surgery
University of Alabama at Birmingham