Phase II Study of Cetuximab as Monotherapy and First Line Treatment in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin Expressing EGFR.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 14
- 主要终点
- Disease control rate assessed by CT or MRI
研究概览
简要总结
The purpose of this study is to determine whether cetuximab is effective in the treatment of locally advanced or metastatic squamous cell carcinoma of the skin expressing EGFR.
详细描述
Patients with locally advanced or metastatic squamous cell carcinoma (SCC) of the skin are often bad responders to conventional chemotherapy included cisplatin.
The investigation of the EGFR expression may allow identifying new molecular targets for novel therapeutic strategies in patients with locally advanced or metastatic SCC of the skin.
Several publications in the literature for primary lesions and one publication for metastatic lesions showed that EGFR was expressed in 80-90% of SCC of the skin. Immunohistochemistry studies performed at the Gustave Roussy Institute confirm these data: they found an over-expression of EGFR in 90% of patients with metastatic disease. These results are in favor of the investigation of cetuximab in patients with locally advanced or metastatic SCC of the skin expressing EGFR.
Cetuximab is a monoclonal antibody targeted against EGFR administered weekly by intravenous route; it may be prescribed as out hospital to patients with locally advanced or metastatic SCC of the skin expressing EGFR.
Due to the low occurrence of locally advanced or metastatic SCC of the skin, a multicenter trial will be required.
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
- •Histological SCC of the skin expressing (IHC) moderately or highly the EGFR (++ and +++, on a semi-quantitative scale).
- •Locally advanced or metastatic SCC of the skin not suitable for local surgery with documented progression.
- •Presence of at least one measurable target lesion by RECIST criteria.
- •At least one lesion accessible to biopsies.
- •ECOG Performance status <
- •Life expectancy > 3 months.
- •Age > 18 years.
- •Normal hematological (Neutrophils > 1.5x109 cells/l, platelets > 100x109 cells/l), hepatic (bilirubin < 1.5 times the upper limit of the normal range (ULN); alkaline phosphatase and transaminases < 5 x UNL in case of hepatic metastases or < 2.5 x UNL in absence of hepatic metastases) and renal (serum creatinine < 150 micromol/L) functions.
- •Written informed consent.
- •In case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator.
排除标准
- •Prior chemotherapy
- •Prior radiotherapy < 1 month.
- •Prior therapy with agent targeting EGFR
- •Unstable systemic diseases or active uncontrolled infections.
- •Patients (male and female) not using effective contraception if of reproductive potential.
- •Females pregnant or lactating. Women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.
研究组 & 干预措施
cetuximab
cetuximab
干预措施: cetuximab (Drug)
结局指标
主要结局
Disease control rate assessed by CT or MRI
时间窗: 6 weeks
次要结局
- Safety profile.(during treatment or within 30 days after the final administration with a cut-off date at week 48.)
- Time to disease progression.(number of days from the start of treatment to the earliest day of progressive disease)
- Overall survival.(from the first infusion until week 48 or death)
- Duration of response in responder patients at 6 weeks.(time to disease progression)