NCT01621217已完成1 期
Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- To establish maximum tolerable dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab and radiotherapy in patients with locally advanced cancer in the anal region
研究概览
简要总结
- To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region
- To evaluate acute toxicity
- To evaluate late toxicity
- To evaluate response rate
- To evaluate recurrence free survival
- To evaluate overall survival
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
- •Age over 18 years
- •Histologically or cytologically confirmed squamous cell cancer of the anal region (anal canal or anal margin or distal rectum)
- •Stage T2 (≥4 cm) - T4 N0-3 M0 or any T N2-3 M0
- •ECOG performance status 0-1
- •Hb > 100 g/L
- •ANC > 1.5 x 10 9/L
- •Platelets ≥ 100 x 10 9/L
- •Creatinine < 1.5 x ULN
- •Bilirubin < 1.5 x ULN
- •ALAT < 3.0 x ULN
- •Competent to comprehend, sign and date an approved informed consent form
排除标准
- •Previous pelvic irradiation
- •Previous chemotherapy for anal cancer
- •Previous malignancy within the last 5 years, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix uteri
- •Pregnant or nursing females or patients of child-bearing potential not using adequate methods of birth control
- •Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
- •Known hypersensitivity to any of the components of the treatment
- •Clinically significant cardiovascular disease, e.g. cardiac failure (<12 months before treatment start), unstable angina, congestive heart failure, arrythmia requiring medication, or uncontrolled hypertension
- •Known positive test for hepatitis C virus, chronic active hepatitis B infection
- •Known HIV infection
- •Any other condition or therapy which in the investigator´s opinion may pose a risk to the patient or interfere with the study objectives
- •Any investigational agent within 30 days before enrolment
- •Surgery (excluding diagnostic biopsy or central venous catheter placement) and/or radiotherapy within 28 days prior to inclusion in the study
研究组 & 干预措施
Cetuximab, Mitomycin C, Fluoruracil
Experimental
干预措施: Cetuximab (Drug)
Cetuximab, Mitomycin C, Fluoruracil
Experimental
干预措施: Mitomycin C (Drug)
Cetuximab, Mitomycin C, Fluoruracil
Experimental
干预措施: 5-Fluoruracil (Drug)
Cetuximab, Mitomycin C, Fluoruracil
Experimental
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
To establish maximum tolerable dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab and radiotherapy in patients with locally advanced cancer in the anal region
时间窗: Participating patients will be followed during the study period; 8 weeks.
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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