Phase II Study of RT Concurrent w/ Cetuximab in Patients w/ Locally Advanced Head & Neck SCC Who Do Not Qualify For Standard Chemotherapy Due To Age >70 Or Co-Morbidities
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
研究概览
简要总结
This is a single-arm, phase II trial to characterize the clinical outcome of standard of care, cetuximab concurrent with radiation, in a special population (head and neck cancer patients who cannot tolerate concurrent chemoradiotherapy due to advanced age, poor performance status or concurrent illness), and to determine if biomarker response to a loading dose of cetuximab is predictive of that outcome.
详细描述
Primary Objective 1: Determine changes in tumor EGFR, pEGFR, downstream signaling and novel phosphoproteins following a loading dose of cetuximab in patients who are poor candidates for chemoradiation (age =70 years or with significant co-morbidities) and are therefore treated with cetuximab with radiation.
Primary Objective 2: Characterize clinical outcomes, including local recurrence, progression-free survival and overall survival in these patients, and correlate these clinical outcomes with the changes in tumor EGFR, pEGFR, downstream signaling, and novel phosphoproteins.
Primary Objective 3: Describe the toxicity, in particular mucositis/dysphagia, of this regimen.
Secondary Objective 1: Conduct normal mucosa EGFR assessment for comparison with tumor sample.
Secondary Objective 2: Correlate HPV presence and titer with p53 status and clinical outcome.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or nonresectable head and neck squamous cell carcinomas of the skin.
- •Patients will be limited to:
- •≥ 70 years of age, OR
- •with co-morbidities that preclude treatment with standard platinum-based chemotherapy, as determined by the treating physician, OR
- •KPS ≤ 80, OR
- •Creatinine clearance < 30 cc/min
- •Laboratory criteria:
- •WBC > 3500/ul
- •Granulocyte > 1500/ul
- •Platelet count > 100,000/ul
- •Total Bilirubin < 1.5 X ULN
- •AST and ALT < 2.5 X ULN
- •Patients must give documented informed consent to participate in this study.
排除标准
- •Prior head and neck malignancy, or history of other prior non-head and neck malignancy within the past 3 years (excluding skin cancer and early stage treated prostate cancer).
- •Prior head and neck radiation or chemotherapy.
- •Documented evidence of distant metastases.
- •Patients with nasopharyngeal carcinoma.
- •Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment.
- •Patients with psychiatric/social situations that would limit compliance with study requirements are not eligible.
- •Patients with prior anti-epidermal growth-factor receptor antibody therapy (antibody or small molecule).
- •Patients residing in prison.
研究组 & 干预措施
Treatment
干预措施: Cetuximab (Drug)
Treatment
干预措施: 50-60 Gy and 70 Gy (Radiation)
结局指标
主要结局
Mean Change in Tumor Epidermal Growth Factor Receptor (EGFR)
时间窗: At baseline (pre-loading dose) and day 7 post-loading dose
The ratio (fold change) of tumor EGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Mean Change in Tumor Phosphorylated EGFR (pEGFR)
时间窗: At baseline (pre-loading dose) and day 7 post-loading dose
The ratio (fold change) of tumor pEGFR post-loading dose/pre-loading dose of cetuximab. Reported as the mean of fold changes across all participants who had an evaluable tumor sample.
Progression Free Survival Rate
时间窗: At 1 and 2 years
Percentage of participants who survived without recurrent disease, from the time of enrollment to 1 and 2 years.
Overall Survival Rate
时间窗: At 1 and 2 Years
Percentage of participants alive at 1 and 2 years after enrollment.
Number of Participants With Treatment Related Toxicities
时间窗: 3 years
Toxicities are measured by number of participants who experience one or more types or indicator of toxicity, shown as all grades and grades 3-4. As each participant could have multiple toxicities, the total number of incidents outnumbers the number of participants. Toxicities are graded according to the CTCAE v4.
次要结局
- Change in Tumor EGFR Level Relative to EGFR in Normal Mucosa(At baseline (pre-loading dose) and day 7 post-loading dose)
- Change in Tumor pEGFR Level Relative to pEGFR in Normal Mucosa(At baseline (pre-loading dose) and day 7 post-loading dose)