A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
研究概览
简要总结
To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
详细描述
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.
The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
- •Stage IV disease (T4Nany or TanyN2-3).
- •"Oligometastatic" disease is allowable if it is asymptomatic.
- •Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is <40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.
- •Performance status 0-
- •Creatinine < or = 1.5 mg/dl.
- •ANC > or = 1,800 cells/mm
- •Platelets > or = 150,000 cells/mm
- •Hemoglobin > or = 10 g/dl (transfusion is acceptable if needed).
- •SGOT and/or SGPT < or = 2.5 times the upper institutional limit of normal.
- •INR < or = 2.
- •Age > or = 18 (informed consent).
排除标准
- •Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
- •Poorly controlled blood pressure, defined as systolic bp > 150 and/or diastolic bp > 100 despite medication.
- •Unstable angina.
- •NY Heart Association (NYHA) Grade II or greater congestive heart failure.
- •History of myocardial infarction or stroke within 6 months.
- •Clinically significant peripheral vascular disease.
- •Evidence of bleeding diathesis or coagulopathy.
- •Presence of brain or spinal cord metastases.
- •Major surgical procedure(s), open biopsy or significant traumatic injury within 28 days prior to Day 1 (1st day of study treatment) and/or anticipation of need for major surgical procedure during the course of the study.
- •Urine protein: Creatinine ratio > or = 1.0 at screening.*
- •Carotid artery exposure or other signs of impending carotid artery hemorrhage.
- •History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.
- •Serious, non-healing wound, ulcer, or bone fracture.
- •Prior irradiation that would result in radiotherapy field "overlap."
- •Requirement for high dose oral anticoagulation (i.e., goal INR > 2.0). "Mini-dose" anticoagulation as may be used to assist in patency of central venous lines is acceptable. Subcutaneous Low-molecular weight heparin is allowable.
- •No known allergies to any of the drug therapies being used in this protocol.
- •No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
研究组 & 干预措施
Treatment
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
干预措施: Cisplatin (Drug)
Treatment
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
干预措施: Docetaxel (Drug)
Treatment
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
干预措施: Bevacizumab (Drug)
Treatment
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
干预措施: Erlotinib (Drug)
Treatment
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
时间窗: Day 36
To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
次要结局
- Complete Remission Rate(6 months)
- Determination of Dose Limiting Toxicity (DTL)(30 days)