Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified squamous cell carcinoma of the head and neck where curatively intended local treatment is not possible.
- •Measurable or non-measurable disease.
- •Disease progression during or after first line palliative chemotherapy with cisplatinum or patients with recurrence < 6 months after primary concomitant chemo-radiotherapy with cisplatinum.
- •WHO Performance Status 0-
- •Age ≥ 18 years.
- •Neutrophil count (ANC) ≥ 1.5 x 10^9/l and platelets ≥ 100 x 10^9/l.
- •Normal liver function with bilirubin < 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases.
- •Creatinin clearance ≥ 50 ml/min.
- •Signed informed consent.
排除标准
- •Other active malignant disease.
- •Patients who are considered unable to follow the treatment plan or follow-up visits.
- •Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1 year, active infection).
- •Any condition or treatment which after the opinion of the investigator may expose the patient to a risk or may influence the purpose of the trial.
- •Pregnant or lactating women.
- •Known hypersensitivity towards one or more of the components of the treatment.
- •Prior treatment with either cetuximab or other inhibitors of EGFR.
研究组 & 干预措施
Chemotherapy
Patients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week.
Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment.
干预措施: Cetuximab (Drug)
Chemotherapy
Patients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week.
Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment.
干预措施: Carboplatin (Drug)
Chemotherapy
Patients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week.
Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment.
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Response rate
时间窗: 3 years
Progression-free survival
时间窗: 2.5 years
次要结局
- Median survival(3 years)
- Correlation between response and evolvement in tumor biology markers.(3 years)
- Toxicity(2.5 years)
研究者
Per Pfeiffer
Professor
Odense University Hospital